The 2015 Quality Management System Vendor Benchmark Report is a survey across industries and geographies on IT/Technology systems used today for Quality Management. Survey had 700+ participants worldwide. Comparisons to 2014 Benchmark are also included. A complete Vendor Listing is located in the Appendix.

2. INTRODUCTION
The purpose of this survey was to collect data from companies on enabling technology currently used to support
key areas of their Quality Management System.
Data was collected from the LinkedIn Quality & Regulatory Network group representing over 100,000
professionals worldwide. Over 716 members from multiple industries participated.
Percentages do not reflect data for market share, only selections from survey participants.
Listing of all Software Vendors mentioned by participants in this survey can be found in the Appendix. Not all
vendors may be represented in their category. If you are a Vendor that is not currently on our list, we welcome the
chance to have you participate in the 2016 QMS Vendors Benchmark Survey.
Any questions about this Survey can be sent to Nikki Willett, Founder/Owner LinkedIn Quality & Regulatory
Network.
The Quality & Regulatory Network would like to thank Hiren Patel and Jacqueline Birkel for their help in creating
this report. I would also like to give special recognition and thanks to C.M. Schramm for her on-going support and
her help in getting this report finished.
2Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
LinkedIn, the LinkedIn logo, the IN logo and InMail are registered trademarks or trademarks of
LinkedIn Corporation and its affiliates in the United States and/or other countries. All other references
to company and product names are copyright in their own right.
Copyright 2015. Quality & Regulatory Network by Nikki Willett. All rights reserved.

3. OBSERVATIONS
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 3
The top 5 vendors selected
overall cover 37% of the total
vendor footprint
 MasterControl
 Trackwise (Sparta Systems)
 SAP
 ACE (PSC Software)
 SharePoint
Manual processes still
predominant over automation
Of the companies leveraging 100%
SaaS solutions, 50% were small
companies ($1-25M revenue)
On average, companies’ oldest
systems (>10 years) are their
Calibration, EH&S, MES, PLM, SPC
and Supplier Quality systems
(43%)
Most companies’ systems are
between 1-3 years old (57%).
Increase of participants from
discrete industries such as Medical
Device
Custom developed systems
reducing probably to adoption
of available Out-of-the-Box
applications
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

4. Demographics
SaaS / Cloud Systems Used
Internal/External Audit
Calibration & Maintenance
CAPA (Corrective & Preventive Actions)
Change Control
Complaints
Document Management
Exceptions (Deviations, Nonconformances)
Environmental Health & Safety (EH&S)
Laboratory Management (LIMS, ELN)
Manufacturing Execution System (MES)
Product Lifecycle Management (PLM)
Statistical Process Control (SPC/PAT)
Supplier Quality
Training
Selected Comments from Participants
Appendix I – Selected Vendor Profiles
Appendix II – Vendor List

5. DEMOGRAPHICS
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR INDUSTRY
5Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
Note: Some answers were consolidated under one industry while those with only a single response were allocated to "Other."
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
2015
COMPARISON
TO 2014
TOC

6. DEMOGRAPHICS 2015
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR COMPANY ANNUAL REVENUE
6Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
Annual Revenue
2015
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Annual Revenue
Comparison to 2014
33.1%
27.9%
12.2%
26.8%
less than 25M 26-500M
500-999M more than 1B
TOC

7. DEMOGRAPHICS – COMPARISON 2014
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR ROLE OR FUNCTION WITHIN
THE COMPANY
7Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
Role / Function
2015
Role / Function
Comparison to 2014
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
8.2% 5.7%
8.7%
3.1%
50.7%
7.5%
2.7% 13.4%
Compliance
C-Suite/Executive Office
IT
Manufacturing
Quality
Regulatory
R&D
Other
TOC

8. DEMOGRAPHICS 2015
REPRESENTATION FROM PARTICIPANTS ABOUT THEIR GEOGRAPHICAL REGION
8Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
Geographical Regions
2015
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
TOC

9. PERCENT OF SAAS / CLOUD-BASED SYSTEMS USED
FOR QUALITY MANAGEMENT SOLUTIONS
9Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
14.0%
7.8%
5.1%
7.4%
7.6%
8.5%
Less than 10%
Between 11-25%
Between 26-50%
Between 51-75%
Between 76-99%
100% are SaaS/Cloud
based
100% SaaS/Cloud!Growing Trend
TOC

10. Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 10
Please note that each Category has three parts:
• 2015 Response
• Time & Satisfaction with the System
• Vendor list of those with less than 1% response
For those Categories that were in the 2014 QMS
Benchmark, we have provided an additional page
to show the 2015 vs. 2014 comparison.

11. 11
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
INTERNAL/EXTERNAL AUDIT
TOC

12. TIME & SATISFACTION WITH AUDIT SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 12
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.75
Predominant System Usage: 1-3 years
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
TOC

13. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 13
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

14. OTHER VENDORS FOR AUDIT*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 14
ActiveQ (Open Mind Solutions)
AssurX
Audit Weaver
BLUe-CAT Synergy
CAQ AG
Cebos
Centurion Quality Management
CIQA
CIS Software
CloudQMS (Cambio Services LLC)
Compliance 360 (SAI Global)
Compliance Control
ComplianceQuest
Enovia PLM (Dassault Systemes)
Entropy (BSI)
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
GMPPro (MOTTO Systems)
Greenlight.Guru
GSQA (EMNS Inc.)
Harrington Group International
IBS US
Ideagen PLC
IHS
Infotehna
Intelex
Interax Group
Integrum Management Systems
IQRC, Inc.
IQS, Inc.
Isoma (E Squared UK)
isoTracker (Lenox Hill Ltd.)
isoXpress (AQA Company)
MetricStream
Microsoft Navision
Montium
Muddy Boots Software
New Generation Computing,
Inc. (NGC)
NextDocs
Novatek International
Omnex
Optiva PLM (Infor)
Oracle
Pastel Auditor (Sage)
Pilgrim Quality Solutions
Q5 Systems
QAD
QAI (Quality Institute of
America)
QMSrs Ltd
QPR Software PLC
QT9 (World Quality Systems)
Quality Link Software
Quality Systems Toolbox
Qualtrax
Quarta (Blulink)
Qumas (Dassault Systemes)
Rescop
Rivo Safeguard
Salesforce
New Generation Computing,
Inc. (NGC)
NextDocs
Novatek International
Omnex
Optiva PLM (Infor)
Oracle
Pastel Auditor (Sage)
Sercle QMS
ServiceNOW
SimpleTrak (ION Quality
Systems)
SoftExpert Software
Solabs
Sword Achiever
The Lean Machine
Tip Technologies
Title21 Health Solutions
uniPoint Software
Verse Solutions
Vintara
Windchill Quality Suite (PTC)
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

15. 15
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
CALIBRATION AND MAINTENANCE
TOC

16. TIME & SATISFACTION WITH CALIBRATION AND
MAINTENANCE SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 16
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.38
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

17. OTHER VENDORS FOR CALIBRATION AND
MAINTENANCE*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 17
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
4Sight (GE)
A2Z Manager (Reetec)
Access Automation
ActiveQ (Open Mind Solutions)
Ambrit
Ape Software
Aras Corp
AssetSmart
Bright Interactive
Caliber Series (Dhruthi Technologies)
Caliso
Calspex (Vantek Software)
CalTrak (Transcat)
CAMA Software LLC
Cebos
CERDAC (Simco Electronics)
ChartHouse Data Management
CIQA
CIS Software
CMX (Beamex)
CompuCal Calibration Solutions
CPRO 2000 Plus (BDR Systems)
DataLyzer
EasyCal (Time Electronics)
ETQ
Fast Track (Aust) Pty LTD.
GageControl (Quality Software
Concepts)
Gage Insite (Indysoft
Corporation)
GageList (Expresso Moon)
GageManager (Altegra)
GAGEpack (PQ Systems)
Grand Avenue Software
Greenlight.Guru
Harrington Group International
iBASEt
IBS US
IN-CAL
Infor
Interax Group
Integrum Management Systems
IQMS
IQRC, Inc.
IQS, Inc.
MAPEX Software
Neomatics
Novatek International
Omnex
ProCAL (Prime Technologies)
QAD
QAI (Quality Institute of America)
QMSrs Ltd
Qualisyst Ltd.
Quality Link Software
Quality Systems Toolbox
Rescop
Sercle QMS
SimpleTrak (ION Quality
Systems)
Sirwill FBM (Global Quality
Village)
SISTRADE Solutions
SoftExpert Software
SoftTech Health LLC
Solabs
Tech-X (Cetex)
Title21 Health Solutions
TrackPro
uniPoint Software
Vintara
Visual Enterprise Solutions
V-Soft computers
Wonderware (Invensys /
Schneider Electric)
xTrak (usCalibration)

18. CAPA (CORRECTIVE & PREVENTATIVE ACTION)
18
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 4 Q u a l i t y & R e g u l a t o r y N e t w o r k
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Manual
CustomDeveloped
ACE(PSC
Software)
AgilePLM(Oracle)
ETQ
GMPPro(MOTTO
Systems)
iCOLOGIQ(formerly
QualityOnline)
MasterControl
QASystems
(QASYS)
Q-Pulse(Gael)
SAP
SharePoint
(Microsoft)
Trackwise(Sparta
Systems)
Other
What system or systems do you use for CAPA within your company?
TOC

19. TIME & SATISFACTION WITH CAPA SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 19
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.60
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

20. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 20
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

21. OTHER VENDORS FOR CAPA*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 21
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
123Compliance
ActiveQ (Open Mind Solutions)
Adaptive BMS
AssurX
BLUe-CAT Synergy
Bugzilla
CAMA Software LLC
Cebos
CIQA
CIS Software
CloudQMS (Cambio Services LLC)
Compliance Control
Compliance Quest
Empower PLM (Omnify Software)
Ensur (Docxellent)
Entropy (BSI)
Fast Track (Aust) Pty LTD.
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
Grand Avenue Software
Greenlight.Guru
Harrington Group International
HP Quality Center
iBASEt
IBS US
Ideagen PLC
Infotehna
Intelex
Interax Group
Integrum Management Systems
IQMS
IQRC, Inc
IQS, Inc.
isoTracker (Lenox Hill Ltd.)
JIRA (Atlassian)
Job BOSS (Exact Business Software)
MetricStream
Montium
Neomatics
NetRegulus (PTC)
NextDocs
Novatek International
Omnex
Pilgrim Quality Solutions
ProMation Systems Inc. (PSI)
Q5 Systems
QAI (Quality Institute of America)
QMSrs Ltd
QPR Software PLC
QUAD (Aster Technologies)
Quality Link Software
Quality Systems Toolbox
Qualtrax
Quarta (Blulink)
Qumas (Dassault Systemes)
Redmine
Rescop
ReSol Technologies
Rivo Safeguard
Sercle QMS
ServiceNOW
SimpleTrak (ION Quality Systems)
SoftExpert Software
SoftTech Health LLC
Solabs
Sword Achiever
TeamPage (Traction Software)
Tech-X (Cetex)
Tip Technologies
Title21 Health Solutions
TQS-9000 (ISP Software Solutions)
uniPoint Software
Verse Solutions
Vintara
Vivaldi Software
Windchill Quality Suite (PTC)
ZenQMS (formerly The QAB)

22. CHANGE CONTROL
22
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 4 Q u a l i t y & R e g u l a t o r y N e t w o r k
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Manual
CustomDeveloped
123Compliance
ACE(PSCSoftware)
AgilePLM(Oracle)
Documentum(EMC)
ETQ
GMPPro(MOTTOSystems)
GrandAvenueSoftware
iCOLOGIQ(formerlyQuality
Online)
Infotehna
MasterControl
SAP
SharePoint(Microsoft)
Trackwise(SpartaSystems)
ZenQMS(formerlyThe
QAB)
Other
TOC

23. TIME & SATISFACTION WITH CHANGE CONTROL
SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 23
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.62
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

24. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 24
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

25. OTHER VENDORS FOR CHANGE CONTROL*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 25
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
123Compliance
Aras Corp
Arena Solutions
AssurX
Autodesk PLM
BLUe-CAT Synergy
Bugzilla
CAMA Software LLC
CAQ AG
CIQA
CloudQMS (Cambio Services LLC)
eMatrix/Matrix One PLM (Dassault Systemes)
Empower PLM (Omnify Software)
Enovia PLM (Dassault Systemes)
Ensur (Docxellent)
Entropy (BSI)
Grand Avenue Software
Greenlight.Guru
IBS US
iCOLOGIQ (formerly Quality Online)
Ideagen PLC
IHS
Infotehna
Intelex
IQMS
IQS, Inc.
ISTM (Remedy)
JD Edwards
JIRA (Atlassian)
Kintana (HP/Mercury Interactive)
MetricStream
Montium
NextDocs
Novatek International
Optiva PLM (Infor)
PDXpert PLM (Active Sensing)
Pilgrim Quality Solutions
Q5 Systems
QAD
QA Systems (QASYS)
QUAD (Aster Technologies)
Qualtrax
Qumas (Dassault Systemes)
Rational (IBM)
Rescop
ReSol Technologies
Selerant
Siemens PLM
Solabs
Sopheon
Sword Achiever
Tip Technologies
Title21 Health Solutions
Trace One
Veeva
ZenQMS (formerly The QAB)

26. COMPLAINTS
26Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
5.0%
10.0%
15.0%
20.0%
25.0% Manual
CustomDeveloped
123Compliance
ACE(PSCSoftware)
Argus(Oracle)
ETQ
FastTrack(Aust)PtyLTD.
GMPPro(MOTTOSystems)
iCOLOGIQ(formerlyQuality
Online)
IQMS
MasterControl
PilgrimQualitySolutions
Salesforce
SAP
SharePoint(Microsoft)
Trackwise(SpartaSystems)
WindchillQualitySuite
(PTC)
Other
TOC

27. TIME & SATISFACTION WITH COMPLAINTS
SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 27
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.65
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

28. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 28
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
-15.0%
-10.0%
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
35.0%
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Manual
CustomDeveloped
123Compliance
ACE(PSCSoftware)
Argus(Oracle)
ETQ
FastTrack(Aust)PtyLTD.
GMPPro(MOTTOSystems)
iCOLOGIQ(formerlyQualityOnline)
IQMS
MasterControl
PilgrimQualitySolutions
Salesforce
SAP
SharePoint
Trackwise(SpartaSystems)
WindchillQualitySuite(PTC)
Other

29. OTHER VENDORS FOR COMPLAINTS*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 29
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Aris Global
AssurX
BLUe-CAT Synergy
Breeze Software
Bugzilla
CAMA Software LLC
CAP Software
CAQ AG
CIS Software
CloudQMS (Cambio Services LLC)
Complaints Pro (Coretec Solutions)
Compliance Control
Compliance Quest
Documentum (EMC)
DRM (Donor Dialog)
Entropy (BSI)
ePowerCenter (Astute Solutions)
Ethics Point (NAVEX Global)
eTracker
Everest (Lynk Software)
Grand Avenue Software
Greenlight.Guru
IBS US
Ideagen PLC
Infotehna
Intelex
Interax Group
IQRC, Inc
IQS, Inc.
i-Sight (Customer Expressions)
isoTracker (Lenox Hill Ltd.)
IssueTrak
JIRA (Atlassian)
M3 (Rover Data Systems, LLC)
MetricStream
mHelpDesk
Microsoft Dynamics
Montium
NetRegulus (PTC)
Novatek International
Onyx (Aptean)
Optiva PLM (Infor)
Pinnacle Business Solutions
PIVOTAL (Aptean)
QT9 (World Quality Systems)
QUAD (Aster Technologies)
Quarta (Blulink)
Qumas (Dassault Systemes)
Sage PLM
Samanage
Sercle QMS
ServiceNOW
Siebel (Oracle)
SimpleTrak (ION Quality Systems)
SISTRADE Solutions
Tip Technologies
Title21 Health Solutions
uniPoint Software
Veeva
Velocity Software
Verse Solutions
Vintara
Vivaldi Software

30. DOCUMENT MANAGEMENT
30Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
2.0%
4.0%
6.0%
8.0%
10.0%
12.0%
14.0%
16.0%
18.0%
20.0%
Manual
CustomDeveloped
123Compliance
ACE(PSCSoftware)
AgilePLM(Oracle)
Documentum(EMC)
ETQ
FastTrack(Aust)Pty
LTD.
GMPPro(MOTTO
Systems)
GrandAvenue
Software
iCOLOGIQ(formerly
QualityOnline)
Infotehna
MasterControl
Q-Pulse(Gael)
Qumas(Dassault
Systemes)
SAP
SharePoint(Microsoft)
Veeva
WindchillQualitySuite
(PTC)
ZenQMS(formerlyThe
QAB)
Other
TOC

31. TIME & SATISFACTION WITH DOCUMENT
MANAGEMENT SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 31
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.65
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

32. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 32
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
-20.0%
-10.0%
0.0%
10.0%
20.0%
30.0%
40.0%
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1
Manual
CustomDeveloped
ACE(PSCSoftware)
AgilePLM(Oracle)
Documentum(EMC)
ETQ
FastTrack(Aust)PtyLTD.
GMPPro(MOTTOSystems)
GrandAvenueSoftware
iCOLOGIQ(formerlyQualityOnline)
MasterControl
Q-Pulse(Gael)
Qumas(DassaultSystemes)
SAP
SharePoint(Microsoft)
Veeva
Other

33. OTHER VENDORS FOR DOCUMENT
MANAGEMENT*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 33
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
ActiveQ (Open Mind Solutions)
Arena Solutions
AssurX
BLUe-CAT Synergy
Blue Mountain
CAMA Software LLC
Camstar (Siemens)
Cebos
CIQA
CloudQMS (Cambio Services LLC)
Compliance 360 (SAI Global)
Compliance Control
ComplianceQuest
Documentum (EMC)
eDOCS (OpenText)
Matrix One PLM (Dassault Systemes)
Empower PLM (Omnify Software)
Enovia PLM (Dassault Systemes)
Ensur (Docxellent)
Entropy (BSI)
Epicor
Epiware
Fast Track (Aust) Pty LTD.
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
Greenlight.Guru
Harrington Group International
iBASEt
IHS
Infotehna
Intelex
Interax Group
Integrum Management Systems
IQMS
IQRC, Inc
IQS, Inc.
Kintana (HP/Mercury Interactive)
Lotus Notes
MetricStream
Montium
Neomatics
NextDocs
Novatek International
Omnex
Oracle
Pilgrim Quality Solutions
Q5 Systems
QAI (Quality Institute of America)
QA Systems (QASYS)
QMSrs Ltd
QUAD (Aster Technologies)
Quality Systems Toolbox
Quality-Works (KvalitetsGruppen)
Qualtrax
Quarta (Blulink)
Qumas (Dassault Systemes)
Redmine
Rescop
ReSol Technologies
Rivo Safeguard
Rockwell
ServiceNOW
SIMATIC (Siemens)
SimpleTrak (ION Quality Systems)
SoftExpert Software
Solabs
Sword Achiever
TeamPage (Traction Software)
Tech-X (Cetex)
Tip Technologies
Title21 Health Solutions
uniPoint Software
Verse Solutions
Vintara
Visual Enterprise Solutions
Vivaldi Software
Windchill Quality Suite (PTC)
Windchill PLM (PTC)

34. EXCEPTIONS
(DEVIATIONS, EVENTS, NONCONFORMANCES, OUT OF SPEC/TOLERANCE/TREND)
34Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
30.0%
Manual
CustomDeveloped
123Compliance
ACE(PSC
Software)
AgilePLM(Oracle)
ETQ
GMPPro(MOTTO
Systems)
GrandAvenue
Software
iCOLOGIQ
(formerlyQuality…
JIRA(Atlassian)
MasterControl
Q-Pulse(Gael)
SAP
SharePoint
(Microsoft)
Trackwise(Sparta
Systems)
ZenQMS(formerly
TheQAB)
Other
TOC

35. TIME & SATISFACTION WITH EXCEPTIONS
DEVIATIONS/NON-CONFORMANCES) SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 35
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.79
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

36. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 36
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

37. OTHER VENDORS FOR EXCEPTIONS
DEVIATIONS/NON-CONFORMANCES) *
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 37
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
ActiveQ (Open Mind Solutions)
Arena Solutions
AssurX
BLUe-CAT Synergy
Blue Mountain
CAMA Software LLC
Camstar (Siemens)
Cebos
CIQA
CloudQMS (Cambio Services LLC)
Compliance 360 (SAI Global)
Compliance Control
ComplianceQuest
Documentum (EMC)
eDOCS (OpenText)
Matrix One PLM (Dassault Systemes)
Empower PLM (Omnify Software)
Enovia PLM (Dassault Systemes)
Ensur (Docxellent)
Entropy (BSI)
Epicor
Epiware
Fast Track (Aust) Pty LTD.
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
Greenlight.Guru
Harrington Group International
iBASEt
IHS
Infotehna
Intelex
Interax Group
Integrum Management Systems
IQMS
IQRC, Inc
IQS, Inc.
Kintana (HP/Mercury Interactive)
Lotus Notes
MetricStream
Montium
Neomatics
NextDocs
Novatek International
Omnex
Oracle
Pilgrim Quality Solutions
Q5 Systems
QAI (Quality Institute of America)
QA Systems (QASYS)
QMSrs Ltd
QUAD (Aster Technologies)
Quality Systems Toolbox
Quality-Works (KvalitetsGruppen)
Qualtrax
Quarta (Blulink)
Qumas (Dassault Systemes)
Redmine
Rescop
ReSol Technologies
Rivo Safeguard
Rockwell
ServiceNOW
SIMATIC (Siemens)
SimpleTrak (ION Quality Systems)
SoftExpert Software
Solabs
Sword Achiever
TeamPage (Traction Software)
Tech-X (Cetex)
Tip Technologies
Title21 Health Solutions
uniPoint Software
Verse Solutions
Vintara
Visual Enterprise Solutions
Vivaldi Software
Windchill Quality Suite (PTC)
Windchill PLM (PTC)

38. EH&S COMPLIANCE MANAGEMENT
38Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
Manual
CustomDeveloped
ACE(PSCSoftware)
MSDSonline
SAP
ZLCSoftware
Other
TOC

39. TIME & SATISFACTION WITH EH&S
COMPLIANCE MANAGEMENT SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 39
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.45
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

40. OTHER VENDORS FOR EH&S COMPLIANCE
MANAGEMENT *
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 40
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Affytrac (Affygility Solutions)
Arena Solutions
Aris Global
ASKEHS Engineering
AssessNet
Assure (SHE Software)
BLUe-CAT Synergy
Cintellate (SAI Global)
CIQA
CloudSDS
CMO Software
COMPASS (Process Data Control)
Compli
Cyanic Automation
DataPipe (Knorr Associates)
DoneSafe
e3 Solutions
Ecocion
EcoIntense
ecoLOGIC Systems
eCompliance Management
Solutions
EHASoft
EHelioS
EHS Data Limited
EHS Insight (StarTex Software)
EMEX
EMSolution (Solution Foundry)
Enablon
Entropy (BSI)
Enviance
ERA Environmental Management
Solutions
ETQ
Fast Track (Aust) Pty LTD.
Field iD (Master Lock)
FlexMMS (CGA Software)
Hamsagars
HAZMIN (Logical Technology)
iCOLOGIQ (formerly Quality Online)
ImageWave
IndustrySafe (TRA, Inc.)
Intelex
KMI
Knowledge Global
Medgate
MIRS (A V Systems)
Neosystems
Open Mind Solutions
Proactive Health and Safety
Solutions
ProntoForms
Prospecta Software
QPR Software PLC
Remedy Interactive
Rivo Safeguard
Saeker Systems
Safety Concepts Group
Safety Tracker Software
SafetyReports.com
SafetySync
SFS Chemical Safety
Simply Safety (CCD Systems)
Smaat (Maerix)
SOAR Solutions
SoftExpert Software
Spiramid
uniPoint Software
webOSCAR (Verdi Technology
Assoc.)
ZeraWare

41. LABORATORY MANAGEMENT
41Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those software
vendors with less than a 1% response are not reflected in the chart but are included in the list of other
Vendors.
TOC

42. TIME & SATISFACTION WITH LABORATORY
MANAGEMENT SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 42
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.25
Predominant System Usage: 1-3 years but
close to over 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

43. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 43
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

44. OTHER VENDORS FOR LABORATORY
MANAGEMENT *
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 44
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
ABB LIMS
Accelerys (Dassault Systemes)
Apollo LIMS (Common Cents Systems)
Blaze LIMS (Blaze Systems)
BLISS LIMS (Baytek International)
Clinsys Group
CORE LIMS (Core Informatics)
CSC LIMS
Csols Ltd
Eusoft Srl
IDBS ELN
Labsoft (Computing Solutions)
LIMS / LABWORKS (PerkinElmer)
LabVantage (SQL*LIMS)
mHelpDesk
Novatek International
Oracle Harvest
Rescop
UniLab (Siemens)
Wavefront Software
Zumatrix (Autoscribe Informatics)

45. MANUFACTURING EXECUTION SYSTEM /
MANUFACTURING OPERATIONS MANAGEMENT
45Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those software
vendors with less than a 1% response are not reflected in the chart but are included in the list of other
Vendors.
TOC

46. TIME & SATISFACTION WITH MES/MOM SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 46
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.25
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

47. OTHER VENDORS FOR MES/MOM *
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 47
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Aegis
Apriso (Dassault Systemes)
AspenTech
CIMx Software
Cincom
Critical Manufacturing
Epicor
Eyelit, Inc
Factory (Aptean)
Fusion Systems
HighJump Software
Honeywell Process Solutions
iBASEt
IBS US
iTac Software
JDA
Lighthouse Systems Limited
MAPEX Software
MPDV USA
NetSuite
Performix, Inc
Plex Systems
Prodac Systems
QAD
SIMATIC (Siemens)
SISTRADE Solutions
TrakSYS (Parsec Automation)

48. PRODUCT LIFECYCLE MANAGEMENT (PLM)
48Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those software
vendors with less than a 1% response are not reflected in the chart but are included in the list of other
Vendors.
TOC

49. TIME & SATISFACTION WITH PLM SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 49
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.25
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

50. OTHER VENDORS FOR PLM*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 50
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Aras Corp
Arena Solutions
Autodesk PLM
Dexma
eMatrix/Matrix One PLM (Dassault Systemes)
Empower PLM (Omnify Software)
Enovia PLM (Dassault Systemes)
Greenlight.Guru
IFS
Infor
IQMS
Kalypso
New Generation Computing, Inc. (NGC)
OnePlace (Eclipse Computing Australia Pty Ltd)
PDXpert PLM (Active Sensing)
Selerant
SLIM (InterCAX)
SofTech Inc.
Sopheon
Trace One

51. STATISTICAL PROCESS CONTROL (SPC) / PROCESS
ANALYTICAL TECHNOLOGY (PAT)
51Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Multiple lab products provided by a Vendor were consolidated under the Vendor's name. Those software
vendors with less than a 1% response are not reflected in the chart but are included in the list of other
Vendors.
0.0%
1.0%
2.0%
3.0%
4.0%
5.0%
6.0%
7.0%
8.0%
Manual
CustomDeveloped
Cebos
InfinityQS
IQMS
MicrosoftExcel
Minitab
NorthwestAnalytics
(NWA)
Other
TOC

52. TIME & SATISFACTION WITH SPC/PAT SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 52
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.26
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

53. OTHER VENDORS FOR SPC/PAT*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 53
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Aegis
ASI DataMyte
CAMO Software AS
Cebos
DataLyzer
Dimensional Control Systems
Intrastage
IQS, Inc.
ISP Software Solutions
PlantNet (Altegra)
PQ Systems
QTi
Qualitron Systems
SIMATIC (Siemens)
Sirwill FBM (Global Quality Village)
SoftExpert Software
Symbion Systems, Inc.
Synergy (Zontec)
WinSPC (DataNet Quality Systems)

54. SUPPLIER QUALITY
54Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
TOC

55. TIME & SATISFACTION WITH SUPPLIER QUALITY
SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 55
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.48
Predominant System Usage: > 10 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

56. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 56
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

57. OTHER VENDORS FOR SUPPLIER QUALITY*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 57
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Adaptive BMS
Aras Corp
Arena Solutions
Ariba
AssurX
Audit Weaver
BLUe-CAT Synergy
CAMA Software LLC
CAQ AG
CIQA
Civerex Systems Inc.
CloudQMS (Cambio Services LLC)
Compliance 360 (SAI Global)
Compliance Control
ComplianceQuest
GAGEtrak/SUPPLIERtrak (CyberMetrics
Corporation)
Documentum (EMC)
Empower PLM (Omnify Software)
Entropy (BSI)
Epicor
EPIQ Technologies, Inc.
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
GSQA (EMNS Inc.)
iBASEt
IBS US
Infor
Infotehna
Intelex
Interax Group
IQMS
IQRC, Inc
IQS, Inc.
JDA
Job BOSS (Exact Business Software)
M3 (Rover Data Systems, LLC)
MetricStream
Microsoft Navision
Muddy Boots Software
Net-Inspect
New Generation Computing, Inc. (NGC)
Pharmschul (GMP Software)
Pilgrim Quality Solutions
Pinnacle Business Solutions
Plex Systems
ProcessPro
QAD
QAI (Quality Institute of America)
QA Systems (QASYS)
Quality Link Software
Quality Systems Toolbox
Qualtrax
Qube Software
Qumas (Dassault Systemes)
Rivo Safeguard
Sercle QMS
SimpleTrak (ION Quality Systems)
Sword Achiever
Tip Technologies
Title21 Health Solutions
TQS-9000 (ISP Software Solutions)
uniPoint Software
Vintara
Visual Enterprise Solutions

58. TRAINING/LEARNING MANAGEMENT
58Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
Note: Some participants may have selected multiple systems if represented within their organizations.
Those software vendors with less than a 1% response are not reflected in the chart but are included in the
list of other Vendors.
TOC

59. TIME & SATISFACTION WITH TRAINING SYSTEM
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 59
Rating for from 1-Awful to 5-Excellent
Average Rating for System: 3.60
Predominant System Usage: 1-3 years
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

60. COMPARISON TO 2014 SURVEY
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 60
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

61. OTHER VENDORS FOR TRAINING/LEARNING
MANAGEMENT*
Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k 61
*Vendors having less than 1% responseTOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015
123Compliance
ActiveQ (Open Mind Solutions)
AssurX
CAMA Software LLC
CAP Software
CAQ AG
Cebos
CIQA
Claromentis
CloudQMS (Cambio Services LLC)
Compliance Control
ComplianceQuest
Cornerstone OnDemand
Dokeos
ecoLOGIC Systems
Matrix One PLM (Dassault Systemes)
Empower PLM (Omnify Software)
Ensur (Docxellent)
Entropy (BSI)
eTraininfo (CIMCON Software)
Fast Track (Aust) Pty LTD.
FlinkISO open source (Techmentis)
Formpipe.GxP (Formpipe Software AB)
GMPPro (MOTTO Systems)
Greenlight.Guru
Halogen Software
Harrington Group International
HealthStream
IBS US
iCOLOGIQ (formerly Quality Online)
iLearning (Seertech)
Infotehna
Intelex
Interax Group
Integrum Management Systems
IQRC, Inc
IQS, Inc.
Learn.com (Oracle)
LearningPlus
MetricStream
Montium
Neomatics
NextDocs
Novatek International
Noverant
Pharmschul (GMP Software)
Pilgrim Quality Solutions
QAI (Quality Institute of America)
QMSrs Ltd
Quality Link Software
Quality Systems Toolbox
Qualtrax
Qumas (Dassault Systemes)
Rescop
ReSol Technologies
Seertech
Sercle QMS
SimpleTrak (ION Quality Systems)
SoftExpert Software
SumTotal
Sword Achiever
Taleo (Oracle)
TEDS Inc.
Tip Technologies
Title21 Health Solutions
TMS (Collaborative Quality Systems)
TQS-9000 (ISP Software Solutions)
uniPoint Software
uPerform (ANCILE)
Verse Solutions
Vintara
Vivaldi Software
ZenDoc (GetZenDoc)

62. 62Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k

63. SELECTED COMMENTS BY PARTICIPANTS
63Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
• We want regulatory agencies to encourage the use of enabling technology for QMS
• From our research, these tools are too expensive for a small company
• In our experience, MasterControl works well in our Manufacturing and Quality Processes and contributed to our Audit success
• We are a PET radiopharmaceutical manufacturer and find that many of the "out-of-the-box" systems are too broad for our
needs.
• There need to be more systems available on a trial basis
• Systems need to have tutorial/demo videos for the main users and stakeholders
• We’re seeing a trend towards purely SaaS solutions where the TCO is very competitive. This simplifies the way software is managed
from a client perspective
• Aadvark is a newer system that we’re leveraging and is set to impact Supply Chain Quality Management
• A simpler User Interface is something we need and want to start seeing among these technologies
• Technologies can be poorly mapped to process because vendors cannot always know what the requirements are
• We have a concern regarding continuous connectivity and speed of processing data
• Our company typically invests more in new product and customer acquisition than they do in QA
• We’re changing our PLM system and are interested in what other companies are doing
• We try to automate a lean process and customize too often in doing so. There need to be more industry-accurate out-of-the-box
functionalities
• Integrated Software that can be added onto existing ERPs could cater to Quality and Supplier Document Management
• We need to increase SaaS conceptual education within our company so that our average employee understands what SaaS is
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

64. SELECTED COMMENTS BY PARTICIPANTS
64Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
• Our group has identified a BI (Business Intelligence) solution sitting on top of core ERP and databases as making the most sense
• My company invests more money in new product and customer acquisition than they do in Quality Assurance.
• We are currently changing to a PLM system and is interested in knowing what people think i.e. the result of the survey
• Integration in existing IT landscape and what is really the single source of truth for quality data
• I want all quality related practices should come under one software
• We often do not define a lean process before we try to automate it. We often try to customize too much instead of utilizing out
of the box
• Global corporate-wide solutions have become the standard. Unfortunately many - even market-leading - SW vendors do often
not offer according technologies / functionality.
• Another typical deficiency are insufficient QMS at the SW vendor, and vendor documentation often does not well support the
validation of the system.
• Responsibility for data entry, and time management negotiations for such activities are sticking points
• Currently our company has LIMS installed and we are in the process of implementing ELN. The reporting aspect of the LIMS
system is severely lacking. The system provides no standard reports; however you can create and validate your own reports
using Crystal Reports. This can become very costly if you do not have the skills in house.
• Lack of harmonization.
• Enterprise Integration Capabilities and if systems are used as true EQMS-platform for all quality related processes. Best of
Breed vs.Enterprise Platforms
TOC
*Source Data: LinkedIn Quality & Regulatory Network Group, June 2015

65. 65Q U A L I T Y & R E G U L A T O R Y N E T W O R K
C o p y r i g h t 2 0 1 5 Q u a l i t y & R e g u l a t o r y N e t w o r k
Interested in having a Vendor Profile in next
year’s Survey? Fill out the 2016 Vendor
Profile Survey (now Open) or watch for next
request in the LinkedIn Quality & Regulatory
Network group in February 2016.

66. 123Compliance Corporation
Website: www.123compliance.com
Contact: Rosalind Beasley
Email: rosalind@123compliance.com
Phone : +1 805 626 8666
HQ: 1525 State Street, Santa Barbara CA 93101 USA
Facts: Number of employees: 1-50
Years in Business, Since: 2012
Annual Revenue: Privately Held
Geographic Regions: Europe, North America
Primary Industries: Biotechnology, Food & Beverages, Medical Device,
Pharmaceuticals
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, Exception Management (deviations, non-
conformances, OOS, OOT, events), Quality Risk Management, Root
Cause/Failure Mode Analysis Tools, Training Management
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (multi-tenant)
123Compliance is the first regulatory compliance solution built on Salesforce.com,
the leading enterprise cloud platform. Designed specifically for the rigorous
compliance needs of the life science industry, we offer out-of-the-box functionality to
meet FDA requirements for the pharmaceutical, food, and medical device industries.
Empowering companies to connect with customers in entirely new ways,
123Compliance taps into the power of social and mobile cloud technologies to
transform the way our customers sell, service, market, and innovate.
L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 66
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Arena Solutions
Website: www.arenasolutions.com
Contact: Umesh Malhotra
Email: umeshm@arenasolutions.com
Phone : +6505133587
HQ: United States
Facts: Number of employees: 51-200
Years in Business, Since: 2000
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Automotive, Biotechnology, Computer Hardware, Software,
Networking, Consumer Electronics, Goods, Services, Electrical & Electronic
Manufacturing, Industrial Automation, Machinery, Medical Device, Oil, Gas,
Renewables & Energy, Pharmaceuticals, Plastics, Railroad Manufacturing,
Semiconductors, Telecommunications, Transportation/Trucking/Railroad
Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit
Management (Internal/External), CAPA Management, Change Control
Management, Complaints (Product Quality, Technical), Document
Management, EHS (Environmental, Health & Safety) Management, Electronic
Laboratory Notebook (ELN), Equipment Calibration & Maintenance
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Inspection Management (raw material, parts, components),
Laboratory Information Management (LIMS, LIS, LES), Process Analytical
Technology (PAT), Product (Batch/Lot) Quality Release, Quality By Design
(QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools,
Sample Management, Statistical Process Control (SPC), Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (single tenant)
3 of the Top 5 Medical Device companies use Arena PLM.

67. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 67
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
AssetSmart
Website: www.assetsmart.com
Contact: Christopher J. Campbell
Email: sales@assetsmart.com
Phone : +310-450-2566
HQ: 2800 28th Street Suite 109, Santa Monica, CA 90405
Facts: Number of employees: 1-50
Years in Business, Since: 1971
Annual Revenue: Privately Held
Geographic Regions: North America
Primary Industries: Defense & Space/Military, Logistics & Supply
Chain, Oil, Gas, Renewables & Energy
Solutions Offered: Equipment Calibration & Maintenance Management,
Test Asset Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise
Founded in 1971, PMSC dba AssetSmart continues to provide industry
leading global asset management and calibration maintenance
management solutions for the Global 2000, space, defense,
communications, electronics and manufacturing companies as well as
major government facilities.
AssurX, Inc.
Website: http://www.assurx.com
Contact: Tamar June
Email: tamar@assurx.com
Phone : +408-778-1376, ext. 705
HQ: 18525 Sutter Blvd. Suite 150, Morgan Hill, CA 95037
Facts: Number of employees: 51-200
Years in Business, Since: 1993
Annual Revenue: Privately Held
Geographic Regions: Europe, Latin America, Middle East, North America
Primary Industries: Biotechnology, Chemicals, Computer Hardware, Software,
Networking, Consumer Electronics, Goods, Services, Cosmetics, Defense &
Space/Military, Financial Services, Food & Beverages, Hospital & Health Care,
Industrial Automation, Information Technology & Services, Medical Device,
Oil, Gas, Renewables & Energy, Packaging & Containers, Pharmaceuticals,
Plastics, Semiconductors, Telecommunications, Tobacco, Utilities
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Inspection Management (raw material, parts, components),
Product (Batch/Lot) Quality Release, Quality Risk Management, Root
Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality
Management (contract services - CMOs, CROs, etc..), Training Management,
eMDR (Electronic Medical Device Reporting), UDI (Unique Device Identifier)
system reporting
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant)
AssurX’s powerfully versatile software unites and coordinates information, activities
and documentation in one reliable enterprise system, effectively managing any
quality-, risk- or compliance-related operations.

68. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 68
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Baytek International
Website: http://www.baytekinternational.com/
Contact: Walter McNeil
Email: walter.mcneil@baytekinternational.com
Phone : +(361) 887-8988
HQ: 401 North Shoreline Blvd, Corpus Christi, TX 78401
Facts: Number of employees: 1-50
Years in Business, Since: 1983
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Chemicals, Computer Hardware, Software, Networking,
Cosmetics, Food & Beverages, Industrial Automation, Information Technology
& Services, Oil, Gas, Renewables & Energy, Pharmaceuticals, Plastics,
Utilities, Wine & Spirits
Solutions Offered: Laboratory Information Management (LIMS, LIS, LES). Product
(Batch/Lot) Quality Release, Sample Management, Statistical Process Control
(SPC), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: 3rd Party Hosted, SaaS (multi-tenant), SaaS (single tenant), On-Premise
VortalBLISS, Baytek International's all web LIMS for the Chemical, Refining, Petrochemical, Water,
and Pharmaceutical process industries. Innovative architecture and leading technology shortens
implementation time, reduces cost, and provides zero footprint workstation and rugged security.
Enterprise Product Spec Management offers secure web interface and integrated automation.
iPRO offers instrument interface for all types of instruments: GC, GC/MS, etc.. TurboTube offers
patented vial distribution for the entire laboratory. BayID offers advanced RFID sample tracking for
exact time/location sample collecting. Ask about our Award Winning 24-7 Support.
CAMA Software, LLC
Website: http://camasoftware.com/
Contact: Carl Kern
Email: carlkern@camasoftware.com
Phone : +949 766-1607
HQ: 19 Gingham St. Suite 100, Trabuco Canyon, CA 92679
Facts: Number of employees: 1-50
Years in Business, Since: 2001
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, Latin America, Middle East, North
America
Primary Industries: Biotechnology, Chemicals, Consumer Electronics, Goods,
Services, Cosmetics, Defense & Space/Military, Electrical & Electronic
Manufacturing, Food & Beverages, Industrial Automation, Logistics & Supply
Chain, Machinery, Medical Device, Packaging & Containers, Pharmaceuticals,
Plastics
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Change Control Management, Complaints (Product Quality, Technical),
Document Management, Equipment Calibration & Maintenance
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Quality By Design (QbD), Quality Risk Management, Root
Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier Quality
Management (contract services - CMOs, CROs, etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise
QCBD’s software suite is an affordable and fully integrated Quality Management
Software for managing all your quality system data. Designed specifically for
manufacturing companies, QCBD dramatically reduces the cost of achieving and
maintaining compliance to quality management. Manage Standards ISO 9001, ISO
13485, AS9100, TS 16949 and SQF 2000 / ISO 22000.

69. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 69
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
CEBOS
Website: www.cebos.com
Contact: Bob Herdoiza
Email: bob@cebos.com
Phone : +820.534.2222
HQ: 5936 Ford Court Suite 203, Brighton, MI 48116
Facts: Number of employees: 51-200
Years in Business, Since: 1995
Annual Revenue: 101-500M
Geographic Regions: Asia Pac, Europe, Latin America, North America
Primary Industries: Automotive, Biotechnology, Chemicals, Food & Beverages,
Furniture, Medical Device, Pharmaceuticals, Plastics, Railroad Manufacturing,
Semiconductors, Telecommunications
Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit
Management (Internal/External), CAPA Management, Change Control
Management, Complaints (Product Quality, Technical), Document
Management, EHS (Environmental, Health & Safety) Management, Equipment
Calibration & Maintenance Management, Exception Management (deviations,
nonconformances, OOS, OOT, events), Inspection Management (raw material,
parts, components), Product (Batch/Lot) Quality Release, Quality By Design
(QbD), Quality Risk Management, Root Cause/Failure Mode Analysis Tools,
Sample Management, Statistical Process Control (SPC), Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant)
Compliance Control Ltd.
Website: WWW.COMPLIANCE-CONTROL.COM
Contact: David Forrest
Email: DAVID.FORREST@COMPLIANCE-CONTROL.COM
Phone : +44 1606871113
HQ: Winnington Hall, Winnington, Northwich, Cheshire CW8 2AS United Kingdom
Facts: Number of employees: 1-50
Years in Business, Since: 2006
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Middle East, North America
Primary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverages,
Hospital & Health Care, Information Technology & Services, Medical Device,
Pharmaceuticals
Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit
Management (Internal/External), CAPA Management, Change Control
Management, Complaints (Product Quality, Technical), Document
Management, EHS (Environmental, Health & Safety) Management, Equipment
Calibration & Maintenance Management, Exception Management (deviations,
nonconformances, OOS, OOT, events), Quality Risk Management, Training
Management
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (multi-tenant)
The system is an ISPE GAMP 3 Categorized system, which means for clients that need a formally
validated system in line with MHRA/FDA, etc.. requirements ComplianceControl Centre can be up
and running and formally validated within 4,5 days ! For lesser regulated clients, users can be up
and running within 1 hour.

70. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 70
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
ComplianceQuest
Website: www.compliancequest.com
Contact: Jack Thomas
Email: info@compliancequest.com
Phone : +408-458-8343
HQ: United States
Facts: Number of employees: 1-50
Years in Business, Since: 2014
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, North America
Primary Industries: Automotive, Biotechnology, Chemicals, Computer
Hardware, Software, Networking, Consumer Electronics, Goods, Services,
Cosmetics, Defense & Space/Military, Electrical & Electronic Manufacturing,
Industrial Automation, Medical Device, Package/Freight Delivery, Packaging &
Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Railroad
Manufacturing, Semiconductors, Tobacco, Transportation/Trucking/Railroad,
Warehousing, Wholesale, Wine & Spirits
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Equipment Calibration & Maintenance Management, Exception
Management (deviations, nonconformances, OOS, OOT, events), Quality Risk
Management, Root Cause/Failure Mode Analysis Tools, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management, Social Collaboration, Reporting & Analytics
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (multi-tenant)
Our solution is built using Force.com technologies. We are the only solution in the
EQMS space that has an enterprise grade solution and running on an enterprise
grade multi-tenant oriented cloud platform. Furthermore, we have a very strong
mobile strategy. All of the solutions we offer has a mobile component and allows to
access, view, approve, create records using Mobile. This would also be a industry
first.
CyberMetrics Corporation
Website: http://www.cybermetrics.com
Contact: Chris Richardson
Email: sales@cybermetrics.com
Phone : +1-800-777-7020
HQ: 1523 W. Whispering Wind Drive Suite 100, Phoenix, AZ 85085
Facts: Number of employees: 1-50
Years in Business, Since: 1988
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle
East, North America
Primary Industries: All industries
Solutions Offered: Equipment Calibration & Maintenance Management,
Quality Risk Management, Supplier Quality Management (contract
services - CMOs, CROs, etc..)
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd
Party Hosted

71. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 71
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
DataLyzer International
Website: www.datalyzer.com
Contact: John Hall
Email: sales@datalyzer.com
Phone : +248-960-3535
HQ: 29445 Beck Road, A207, Wixom, MI 48393
Facts: Number of employees: 1-50
Years in Business, Since: 1979
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Automotive, Biotechnology, Building Materials, Chemicals,
Consumer Electronics, Goods, Services, Cosmetics, Defense &
Space/Military, Food & Beverages, Glass, Ceramics & Concrete, Machinery,
Medical Device, Oil, Gas, Renewables & Energy, Packaging & Containers,
Paper & Forest Products, Pharmaceuticals, Plastics, Railroad Manufacturing,
Semiconductors, Tobacco, Wine & Spirits
Solutions Offered: APQP (Advanced Product Quality Planning), CAPA Management,
Equipment Calibration & Maintenance Management, Inspection Management
(raw material, parts, components), Quality By Design (QbD), Quality Risk
Management, Root Cause/Failure Mode Analysis Tools, Sample
Management, Statistical Process Control (SPC), Supplier Quality Management
(contract services - CMOs, CROs, etc..), OEE, FMEA, MSA
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise
Available in 18 languages, offices in USA, Europe and Asia and experienced
distributors in major countries
Dimensional Control Systems
Website: www.3dcs.com
Contact: Benjamin Reese
Email: breese@3dcs.com
Phone : +2482699777
HQ: 580 Kirts Blvd, Suite 309, Troy, MI 48084
Facts: Number of employees: 51-200
Years in Business, Since: 1994
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, Latin America, North America
Primary Industries: Automotive, Consumer Electronics, Goods, Services,
Defense & Space/Military, Electrical & Electronic Manufacturing, Machinery,
Medical Device, Oil, Gas, Renewables & Energy
Solutions Offered: APQP (Advanced Product Quality Planning), Exception
Management (deviations, nonconformances, OOS, OOT, events), Inspection
Management (raw material, parts, components), Root Cause/Failure Mode
Analysis Tools, Statistical Process Control (SPC), Supplier Collaboration,
Supplier Quality Management (contract services - CMOs, CROs, etc..)
License Type: On-Premise
Dimensional Control Systems (DCS) is an engineering services and software provider.
We provide QDM, our QMS system, as well as 3DCS, our CAD based simulation tool,
as well as services which can provide a customer a short term proof of concept or
case study to demonstrate value of the products. We have a global partner network to
provide support in all of our serviced regions.

72. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 72
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
DocXellent
Website: www.docxellent.com
Contact: Gary Carignan
Email: gcarignan@docxellent.com
Phone : +860-887-2900
HQ: 257 Main Street, Norwich, CT 06360
Facts: Number of employees: 1-50
Years in Business, Since: 1983
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, Latin America, Middle East, North
America
Primary Industries: Biotechnology, Chemicals, Cosmetics, Education
Management/E-learning, Electrical & Electronic Manufacturing, Food &
Beverages, Gambling & Casinos, Hospital & Health Care, Industrial
Automation, Medical Device, Oil, Gas, Renewables & Energy, Packaging &
Containers, Pharmaceuticals, Semiconductors, Telecommunications, Utilities
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Change Control Management, Complaints (Product Quality, Technical),
Document Management, Equipment Calibration & Maintenance
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Product (Batch/Lot) Quality Release, Quality Risk Management,
Supplier Quality Management (contract services - CMOs, CROs, etc..), Training
Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), 3rd Party Hosted
EMNS, Inc.
Website: www.gsqa.com
Contact: John McGlinn
Email: john.mcglinn@emns.com
Phone : +888.900.5033
HQ: 2815 Centre Circle Dr., Downers Grove, IL 60515
Facts: Number of employees: 1-50
Years in Business, Since: 2001
Annual Revenue: Privately Held
Geographic Regions: North America
Primary Industries: Building Materials, Chemicals, Consumer Electronics,
Goods, Services, Defense & Space/Military, Electrical & Electronic
Manufacturing, Food & Beverages, Glass, Ceramics & Concrete, Machinery,
Mining & Metals, Oil, Gas, Renewables & Energy, Packaging & Containers,
Paper & Forest Products, Plastics, Railroad Manufacturing, Semiconductors,
Supermarkets, Telecommunications, Tobacco,
Transportation/Trucking/Railroad, Wine & Spirits
Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management
(Internal/External), CAPA Management, Change Control Management,
Complaints (Product Quality, Technical), Document Management, EHS
(Environmental, Health & Safety) Management, Electronic Laboratory
Notebook (ELN), Exception Management (deviations, nonconformances, OOS,
OOT, events), Inspection Management (raw material, parts, components),
Laboratory Information Management (LIMS, LIS, LES), Process Analytical
Technology (PAT), Product (Batch/Lot) Quality Release, Quality Risk
Management, Sample Management, Statistical Process Control (SPC),
Supplier Collaboration, Supplier Quality Management (contract services -
CMOs, CROs, etc..)
FDA 21 Part 11 Compliant: No
License Type: SaaS (single tenant), SaaS (multi-tenant)

73. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 73
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
E Squared UK Ltd
Website: www.isoma.systems
Contact: David Key
Email: sales@esquaredgroup.co.uk
HQ: 2 Wellington Place, Leeds LS1 4AP United Kingdom
Facts: Number of employees: 1-50
Years in Business, Since: 2008
Annual Revenue: 1-25M
Geographic Regions: Asia Pac, Europe, Middle East, North America
Primary Industries: Automotive, Construction, Defense & Space/Military,
Electrical & Electronic Manufacturing, Logistics & Supply Chain,
Telecommunications
Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit
Management (Internal/External), CAPA Management, Change Control
Management, Document Management, EHS (Environmental, Health & Safety)
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Process Analytical Technology (PAT), Product (Batch/Lot)
Quality Release, Quality By Design (QbD), Quality Risk Management, Root
Cause/Failure Mode Analysis Tools, Sample Management, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..)
FDA 21 Part 11 Compliant: No
License Type: On-Premise, SaaS (multi-tenant), 3rd Party Hosted
Isoma is enterprise software for building and operating Integrated Management
Systems. Designed for standards management professionals by standards
management professionals it generates insight, drives improvement and refocuses
organizations.
Fast Track (Aust) Pty Ltd
Website: www.fasttrack365.com
Contact: Greg Carroll
Email: gcarroll@fasttrackaust.com
HQ: Level 4, 50 Marine Pde, Southport, QLD 2415 Australia
Facts: Number of employees: 1-50
Years in Business, Since: 1981
Annual Revenue: 1-25M
Geographic Regions: Africa, Asia Pac, Middle East
Primary Industries: Defense & Space/Military, Gambling & Casinos, Hospital
& Health Care, Mining & Metals, Utilities, Govt Administration
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Change Control Management, Complaints (Product Quality, Technical),
Document Management, EHS (Environmental, Health & Safety) Management,
Equipment Calibration & Maintenance Management, Exception Management
(deviations, nonconformances, OOS, OOT, events), Inspection Management
(raw material, parts, components), Product (Batch/Lot) Quality Release,
Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management, Governance - Objectives, KPIs, Obligations,
Strategic Planning
FDA 21 Part 11 Compliant: Not assessed
License Type: On-Premise, SaaS (single tenant)
For 30 years Fast Track has specialized in regulatory compliance and enterprise risk
management for medium and large organizations, providing enterprise solutions for
Quality, Risk, Contract and Asset Management. Clients include Aust Dept of Defence,
Motorola, Serco as well as Utilities and Healthcare industries. Privately owned, based
on the Gold Coast, Australia looking after clients as far afield as Mali and Colombia.
Founded 1981, throughout our longevity our products and services have remained
industry leading, as we are still looking after the likes of Fosters and Motorola since
the early nineties attests. Positioned in the mission critical marketplace and aimed at
those pursuing best practices, our product is about providing insight and decision
making support proactively instead of the traditional record administration approach.

74. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 74
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Formpipe Software AB (Formpipe.GxP)
Website: www.formpipegxp.com
Contact: Keith Williams
Email: info@formpipegxp.com
Phone : +44 115 924 8475
HQ: 13 Populars Court, Lenton Lane, Nottingham NG7 2RR
Facts: Number of employees: 201-500
Years in Business, Since: 1999
Annual Revenue: 1-25M
Geographic Regions: Europe, North America
Primary Industries: Biotechnology, Hospital & Health Care, Medical Device,
Pharmaceuticals
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Document Management, Quality Risk Management, Supplier Quality
Management (contract services - CMOs, CROs, etc.), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted
Formpipe.GxP, the Life Science division of Formpipe Software AB, simplify complex
process and technology environments to help Life Science organizations achieve their
compliance goals. We achieve this through a combination of EQMS Solutions and
Compliance Consultancy that enable our customers to ‘Get Compliant’ and ‘Stay
Compliant’. Founded in 1999, the company has successfully delivered over 350
compliance based projects within the EU and US regulatory landscape. Formpipe.GxP
works with 12 of the top 20 leading global organizations to help them Stay Compliant
with offices in the US, Sweden and the UK. Parent company Formpipe Software AB
develops ECM products and solutions for structuring information and supplies them
to major companies, authorities and organizations. ECM products help organizations
to capture, manage and distribute information, and to place it in context. The
company's software helps improve efficiency, cut costs and reduce risk exposure.
Formpipe was founded in 2004 and has offices in Stockholm, Uppsala and Linköping
in Sweden, and in Copenhagen, Denmark. The Formpipe share is listed on NASDAQ
OMX Nordic
Gael Limited (Q-Pulse)
Website: www.gaelquality.com
Contact: Tony McCutcheon
Email: tonymc@gaelquality.com
Phone : +01355 593 400
HQ: Orion House S.E. Technology Park, East Kilbride, South Lanarkshire G75 0RD
Scotland
Facts: Number of employees: 51-200
Years in Business, Since: 1992
Annual Revenue: 1-25M
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Computer Hardware, Software, Networking, Defense &
Space/Military, Education Management/E-learning, Hospital & Health Care,
Industrial Automation, Information Technology & Services, Logistics & Supply
Chain, Medical Device, Pharmaceuticals, Transportation/Trucking/Railroad,
Other (please specify) Aviation & Rail
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Laboratory Information Management (LIMS, LIS, LES), Quality
Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier Quality
Management (contract services - CMOs, CROs, etc..), Training Management,
Risk Management Compliance Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted

75. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 75
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Grand Avenue Software
Website: www.grandavenue.com
Contact: Ron Schmitz
Email: info@grandavenue.com
Phone : +651-204-1743
HQ: 180 5th St E Suite 256, Saint Paul, MN 55101
Facts: Number of employees: 1-50
Years in Business, Since: 2002
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, Latin America, North America
Primary Industries: Medical Device
Solutions Offered: Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product
Quality, Technical), Document Management, Equipment Calibration
& Maintenance Management, Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, 3rd Party Hosted
greenight.guru
Website: www.greenlight.guru
Contact: Nick Tippmann
Email: nick.tippmann@greenlight.guru
Phone : +260-438-8708
HQ: 1060 N. Capitol Ave Suite C100, Indianapolis, IN 46204
Facts: Number of employees: 1-50
Years in Business, Since: 2013
Annual Revenue: Privately Held
Geographic Regions: Europe, North America
Primary Industries: Computer Hardware, Software, Networking,
Information Technology & Services, Medical Device
Solutions Offered: Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product
Quality, Technical), Document Management, Equipment Calibration
& Maintenance Management, Exception Management (deviations,
nonconformances, OOS, OOT, events), Quality By Design (QbD),
Quality Risk Management, Root Cause/Failure Mode Analysis Tools,
Supplier Quality Management (contract services - CMOs, CROs, etc..),
Training Management
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (multi-tenant)

76. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 76
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Harrington Group International
Website: http://www.hgint.com
Contact: Tom Quinn
Email: tquinnqms@outlook.com
Phone : +256-451-3508
HQ: 111501 Lake Underhill Road, Orlando, FL 32825
Facts: Number of employees: 1-50
Years in Business, Since: 1991
Annual Revenue: 1-25M
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Automotive, Biotechnology, Building Materials, Chemicals,
Computer Hardware, Software, Networking, Construction, Defense &
Space/Military, Electrical & Electronic Manufacturing,
Environmental/Facilities Services, Food & Beverages, Furniture, Hospital &
Health Care, Hospitality, Industrial Automation, Information Technology &
Services, Logistics & Supply Chain, Machinery, Maritime/Shipbuilding,
Medical Device, Mining & Metals, Oil, Gas, Renewables & Energy,
Package/Freight Delivery, Packaging & Containers, Paper & Forest Products,
Pharmaceuticals, Plastics, Semiconductors, Telecommunications,
Transportation/Trucking/Railroad, Utilities, Warehousing, Wholesale
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Equipment Calibration & Maintenance Management, Exception
Management (deviations, nonconformances, OOS, OOT, events), Inspection
Management (raw material, parts, components), Quality Risk Management,
Root Cause/Failure Mode Analysis Tools, Supplier Collaboration, Supplier
Quality Management (contract services - CMOs, CROs, etc..), Training
Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted
Complete QMS & Supplier Quality Management Software Solutions & Consulting Services
HyperTeam USA Inc.
Website: www.hyperteam.com
Contact: Arpad Solti
Email: arpad.solti@hyperteam.com
Phone : +2396879806
HQ: 5841 Cinzano Ct, Naples, FL 34119
Facts: Number of employees: 1-50
Years in Business, Since: 2005
Annual Revenue: 1-25M
Geographic Regions: Europe, North America
Primary Industries: Banking, Biotechnology, Chemicals, Financial
Services, Information Technology & Services, Insurance, Logistics &
Supply Chain, Medical Device, Pharmaceuticals, Retail, Utilities
Solutions Offered: Complaints (Product Quality, Technical), Document
Management, Product (Batch/Lot) Quality Release, Supplier Quality
Management (contract services - CMOs, CROs, etc..), Complaint
Handling SharePoint Solution Policy & Regulation Manager
SharePoint Solution
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd
Party Hosted

77. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 77
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
iBASEt
Website: www.ibaset.com
Contact: Conrad Leiva
Email: cleiva@ibaset.com
Phone : +949-598-5200
HQ: 27442 Portola Pkwy #300, Foothill Ranch, CA 92688
Facts: Number of employees: 51-200
Years in Business, Since: 1986
Annual Revenue: Privately Held
Geographic Regions: Europe, North America
Primary Industries: Defense & Space/Military, Electrical & Electronic
Manufacturing, Industrial Automation, Logistics & Supply Chain, Machinery,
Medical Device, Railroad Manufacturing, Transportation/Trucking/Railroad
Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management
(Internal/External), CAPA Management, Change Control Management,
Equipment Calibration & Maintenance Management, Exception Management
(deviations, nonconformances, OOS, OOT, events), Inspection Management
(raw material, parts, components), Quality Risk Management, Root
Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC),
Supplier Collaboration, Supplier Quality Management (contract services -
CMOs, CROs, etc..), Work Instructions, Engineering and ERP Integration
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise
INFOTEHNA
Website: www.infotehna.com
Contact: Sonja Vlasic
Email: sonja.vlasic@infotehna.com
Phone : +38673930600
HQ: Podbreznik 15, Novo mesto 8000 Slovenija
Facts: Number of employees: 51-200
Years in Business, Since: 1988
Annual Revenue: 1-25M
Geographic Regions: Asia Pac, Europe, Middle East, North America
Primary Industries: Biotechnology, Medical Device, Pharmaceuticals
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Change Control Management, Complaints (Product Quality, Technical),
Document Management, Exception Management (deviations,
nonconformances, OOS, OOT, events), Product (Batch/Lot) Quality Release,
Supplier Quality Management (contract services - CMOs, CROs, etc..),
Validation
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant)
INFOTEHNA is a major provider of the most advanced solutions for managing regulatory data,
documents and processes in the global life sciences industry. Our myPharma Expert Suite of
solutions enables standardization across enterprises and helps users tackle RA, RIM including
Publishing and Submissions management, R&D, QA/QC, PhV and Manufacturing challenges.
Depending on organizations' specific needs, our solution can be modular or integral, and is thus
capable of supporting singular compliance relevant processes or complete enterprise compliance
management. Also, it can be deployed on premises or cloud. By using INFOTEHNA's product, our
clients reduce the time to market for new products and the overall Product Life Cycle Management
effort. Even more importantly, they introduce sustainable compliance as there is no need to
maintain integration between multiple systems. Our myPharma Expert Suite of solutions is easily
configurable and validated and its use increases the overall quality of products, documents, data
and processes. We have an exceptional track record consisting of 25 years of compliance
solutions and products for the Life Sciences industry globally

78. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 78
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Integrum Management Systems Pty Limited
Website: www.integrumsystems.com
Contact: Beven Schwaiger
Email: beven@integrumsystems.com
Phone : +61 2 9663 1004
HQ: Suite 13 6-8 Crewe Place, Rosebery NSW 2018 Australia
Facts: Number of employees: 1-50
Years in Business, Since: 1996
Annual Revenue: 1-25M
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Automotive, Banking, Building Materials, Chemicals,
Construction, Consumer Electronics, Goods, Services, Defense &
Space/Military, Education Management/E-learning, Electrical & Electronic
Manufacturing, Environmental/Facilities Services, Financial Services, Food &
Beverages, Furniture, Glass, Ceramics & Concrete, Hospital & Health Care,
Hospitality, Industrial Automation, Information Technology & Services,
Insurance, Logistics & Supply Chain, Machinery, Maritime/Shipbuilding,
Mining & Metals, Oil, Gas, Renewables & Energy, Package/Freight Delivery,
Packaging & Containers, Paper & Forest Products, Pharmaceuticals, Plastics,
Publishing, Railroad Manufacturing, Retail, Supermarkets,
Telecommunications, Transportation/Trucking/Railroad, Utilities,
Warehousing, Wholesale, Aviation, Waste & Water
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Complaints (Product Quality, Technical), Document
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Inspection Management (raw material, parts, components),
Quality Risk Management, Root Cause/Failure Mode Analysis Tools, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management, Legal Compliance Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted
Since 1996, over 250,000 licensed users in over 40 countries
IQS, Inc.
Website: www.iqs.com
Contact: Karleen Radke
Email: kradke@iqs.com
Phone : +4407882725
HQ: 24950 Country Club Blvd #120, North Olmsted, OH 44070
Facts: Number of employees: 1-50
Years in Business, Since: 1988
Annual Revenue: Privately Held
Geographic Regions: Europe, Latin America, North America
Primary Industries: Automotive, Defense & Space/Military, Medical Device,
Oil, Gas, Renewables & Energy, Plastics
Solutions Offered: APQP (Advanced Product Quality Planning), Audit Management
(Internal/External), CAPA Management, Change Control Management,
Complaints (Product Quality, Technical), Document Management, EHS
(Environmental, Health & Safety) Management, Inspection Management (raw
material, parts, components), Quality Risk Management, Statistical Process
Control (SPC), Supplier Collaboration, Training Management, Calibration
Mgmt, Equipment Mtce, FMEA/Control Plan Mgmt, PPAP/First Article Mgmt,
Inspection/SPC, Analytics
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant)
IQS provides the most comprehensive and user-friendly quality management software
system on the market. IQS stands out in these key areas: -Quality management
through the supply chain with a scalable, enterprise-wide structure -User-friendly,
flexible, configurable quality software -Robust systems integration capabilities -
Configurable quality analytics, dash boarding and reporting -Expert and proven
implementation and technical support

79. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 79
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
MasterControl
Website: www.mastercontrol.com
Contact: Jeff Parr
Email: jparr@mastercontrol.com
Phone : +801-541-9668
HQ: 6330 South 3000 East Suite 200, Salt Lake City, UT 84121
Facts: Number of employees: 201-500
Years in Business, Since: 1993
Annual Revenue: 26-50M
Geographic Regions: Asia Pac, Europe, North America
Primary Industries: Biotechnology, Chemicals, Food & Beverages, Hospital &
Health Care, Logistics & Supply Chain, Medical Device, Oil, Gas, Renewables
& Energy, Packaging & Containers, Pharmaceuticals, Tobacco
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, Equipment Calibration & Maintenance
Management, Exception Management (deviations, nonconformances, OOS,
OOT, events), Inspection Management (raw material, parts, components),
Product (Batch/Lot) Quality Release, Quality By Design (QbD), Quality Risk
Management, Root Cause/Failure Mode Analysis Tools, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant)
Meercat Pty Ltd
Website: www.meercat.com.au
Contact: Alex Apostolou
Email: alex@meercat.com.au
Phone : +61407779879
HQ: Unit 1 362 Fitzgerald Street, North Perth, WA 6006 Australia
Facts: Number of employees: 1-50
Years in Business, Since: 2002
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, North America
Primary Industries: Building Materials, Chemicals, Environmental/Facilities
Services, Logistics & Supply Chain, Maritime/Shipbuilding, Mining & Metals,
Oil, Gas, Renewables & Energy, Package/Freight Delivery, Packaging &
Containers, Paper & Forest Products, Utilities
Solutions Offered: Exception Management (deviations, nonconformances, OOS, OOT,
events), Root Cause/Failure Mode Analysis Tools, Risk Management, Bowtie
visualization, qualitative and quantitative analysis, control assurance, action
tracking, auditing and data analysis.
License Type: On-Premise, SaaS (single tenant)
RiskView supports the Operational Risk Management process of identifying, analyzing and
managing operational risk and enables businesses to integrate risk data into a single
environment. This integrated approach helps improve visibility into risk exposure, reduce loss and
improve business performance. RiskView provides: Single Repository for all Risk Data Enables
unlimited levels of entities, processes, risks and controls to match the structure of your
organization Eliminates redundancies through shared documents, processes, risks and controls
Scenario analysis Provides document management with audit trail capabilities Enables business
units to assess high-impact risk areas and emerging risks Risk indicator tracking Enables you to
track risk metrics and thresholds Supports proactive management of key risks to improve
corporate performance Business intelligence and decision support Provides browser-based
reporting capabilities Delivers reporting on the current state of operational risk across the
organization Lets you drill down through reports for root cause analysis Loss event tracking Offers
statistical and trend analysis capabilities to enable tracking of remedies and action plans
Improves risk measurement and helps minimize losses RiskView allows you to embed operational
risk management practices into the corporate culture, making procedures more effective and
efficient.

80. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 80
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
MOTTO Systems Pvt Ltd.
Website: http://www.quickgmp.com/
Contact: RAJ K
Email: raj@mottosys.com
Phone : +09553444478
HQ: 1ST FLOOR, SAMRIDHI VASYAM, JAIHIND ENCLAVE, MADHAPUR, HYDERABAD TG,
500081, India
Facts: Number of employees: 1-50
Years in Business, Since: 2013
Annual Revenue: 1-25M
Geographic Regions: Asia Pac, North America
Primary Industries: Education Management/E-learning, Information
Technology & Services, Mining & Metals, Pharmaceuticals
Solutions Offered: Audit Management (Internal/External), CAPA Management,
Change Control Management, Complaints (Product Quality, Technical),
Document Management, Electronic Laboratory Notebook (ELN), Equipment
Calibration & Maintenance Management, Exception Management (deviations,
nonconformances, OOS, OOT, events), Inspection Management (raw material,
parts, components), Laboratory Information Management (LIMS, LIS, LES),
Process Analytical Technology (PAT), Product (Batch/Lot) Quality Release,
Root Cause/Failure Mode Analysis Tools, Sample Management, Supplier
Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management, Stability Management Recall and Return
Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), 3rd Party Hosted
A flagship product from Motto Systems, GMPPro is an end to end solution for Life
Science companies. A complete Web based Quality Management System that
facilitates efficient management of Process capabilities, Regulatory and Quality
compliance and documentation with proper cGMP and Quality guidelines. GMPPro is
well fit for Life Sciences, Pharmaceutical and Food manufacturing Industries.
Neomatics (ExpressPack Quality)
Website: www.neomatics.be
Contact: Sven Mus
Email: sven.mus@neomatics.be
Phone : +32 477 56 28 36
HQ: Kattendijkdok Westkaai 53 T2 3.1, Antwerp 2000 Belgium
Facts: Number of employees: 51-200
Years in Business, Since: 2000
Annual Revenue: 1-25M
Geographic Regions: Europe, North America
Primary Industries: Biotechnology, Chemicals, Cosmetics, Food & Beverages,
Hospital & Health Care, Machinery, Medical Device, Package/Freight Delivery,
Packaging & Containers, Pharmaceuticals
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Equipment Calibration & Maintenance Management, Exception
Management (deviations, non-conformances, OOS, OOT, events), Quality By
Design (QbD), Supplier Collaboration, Supplier Quality Management (contract
services - CMOs, CROs, etc..), Training Management, Validation GxP & ISO,
e.g. 15189
FDA 21 Part 11 Compliant: Yes
License Type: 3rd Party Hosted, SaaS (single tenant), On-Premise
We provide both the software solution and services. The services include non software related
items such as QA's, QP's, Tech transfer and Validation.

81. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 81
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Omnify Software
Website: http://www.omnifysoft.com
Contact: Alaine Portnoy
Email: aportnoy@omnifysoft.com
Phone : +9789883800
HQ: 2 Highwood Drive Suite 202, Tewksbury, MA 01876
Facts: Number of employees: 1-50
Years in Business, Since: 2002
Annual Revenue: Privately Held
Geographic Regions: Europe, North America
Primary Industries: Computer Hardware, Software, Networking, Consumer
Electronics, Goods, Services, Defense & Space/Military, Electrical &
Electronic Manufacturing, Medical Device, Semiconductors,
Telecommunications
Solutions Offered: CAPA Management, Change Control Management, Document
Management, Equipment Calibration & Maintenance Management, Supplier
Quality Management (contract services - CMOs, CROs, etc..), Training
Management, Product Lifecycle Management (PLM), Bill of Material (BOM)
Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, 3rd Party Hosted
The Omnify Empower PLM solution provides a single location to track and manage all
product content information. By encompassing Quality Management, customers can
also associate quality information/processes to the product record which helps to
address quality issues early on, provides visibility into quality issues across the entire
organization and eliminates the need for two separate databases (Quality and PLM).
PSC Software
Website: www.pscsoftware.com
Contact: John Clapham
Email: jclapham@biotech.com
Phone : +9097843350
HQ: 700 Corporate Center Drive Suite 201, Pomona, CA
Facts: Number of employees: 201-500
Years in Business, Since: 1996
Annual Revenue: Privately Held
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East,
North America
Primary Industries: Banking, Biotechnology, Chemicals, Computer Hardware,
Software, Networking, Consumer Electronics, Goods, Services, Cosmetics,
Defense & Space/Military, Education Management/E-learning,
Environmental/Facilities Services, Food & Beverages, Furniture, Glass,
Ceramics & Concrete, Hospital & Health Care, Hospitality, Industrial
Automation, Information Technology & Services, Insurance, Logistics & Supply
Chain, Medical Device, Oil, Gas, Renewables & Energy, Packaging &
Containers, Paper & Forest Products, Pharmaceuticals, Plastics, Restaurants,
Retail, Transportation/Trucking/Railroad, Utilities, Wine & Spirits
Solutions Offered: Adverse Events, Audit Management (Internal/External), CAPA
Management, Change Control Management, Complaints (Product Quality,
Technical), Document Management, EHS (Environmental, Health & Safety)
Management, Equipment Calibration & Maintenance Management, Exception
Management (deviations, nonconformances, OOS, OOT, events), Inspection
Management (raw material, parts, components), Product (Batch/Lot) Quality
Release, Quality Risk Management, Sample Management, Supplier Quality
Management (contract services - CMOs, CROs, etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: SaaS (single tenant)
We offer a complete validation package for our software, additionally we do document control, and
full work engine functionality.

82. L I N K E D I N Q U A L I T Y & R E G U L A T O R Y N E T W O R K 82
SELECTED VENDOR PROFILES*
* Vendors submitted profiles in support of the Survey
Pilgrim Quality Solutions
Website: www.pilgrimquality.com
Contact: Patrice Cunningham
Email: patrice.cunningham@pilgrimquality.com
Phone : +8139151663 x2502
HQ: 2807 W. Busch Blvd, Tampa, FL 33549
Facts: Number of employees: 51-200
Years in Business, Since: 1993
Annual Revenue: Privately Held
Geographic Regions: Asia Pac, Europe, Middle East, North America
Primary Industries: Biotechnology, Chemicals, Cosmetics, Medical
Device, Oil, Gas, Renewables & Energy, Packaging & Containers,
Pharmaceuticals, Tobacco, Blood & Tissue
Solutions Offered: Adverse Events, Audit Management (Internal/External),
CAPA Management, Change Control Management, Complaints
(Product Quality, Technical), Document Management, Equipment
Calibration & Maintenance Management, Exception Management
(deviations, nonconformances, OOS, OOT, events), Inspection
Management (raw material, parts, components), Quality Risk
Management, Supplier Quality Management (contract services -
CMOs, CROs, etc..), Training Management
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), 3rd Party Hosted
PTC
Website: www.ptc.com
Contact: Daniel Jacob
Email: dajacob@ptc.com
Phone : +724-953-4853
HQ: 140 Kendrick St, Needham, MA 02494
Facts: Number of employees: 5000+
Years in Business, Since: 1985
Annual Revenue: 1B+
Geographic Regions: Africa, Asia Pac, Europe, Latin America, Middle East, North America
Primary Industries: Automotive, Computer Hardware, Software, Networking, Construction,
Consumer Electronics, Goods, Services, Defense & Space/Military, Electrical & Electronic
Manufacturing, Food & Beverages, Furniture, Glass, Ceramics & Concrete, Hospital &
Health Care, Industrial Automation, Information Technology & Services, Logistics &
Supply Chain, Machinery, Maritime/Shipbuilding, Medical Device, Mining & Metals, Oil,
Gas, Renewables & Energy, Pharmaceuticals, Plastics, Retail, Semiconductors,
Telecommunications, Transportation/Trucking/Railroad
Solutions Offered: Adverse Events, APQP (Advanced Product Quality Planning), Audit Management
(Internal/External),CAPA Management, Change Control Management, Complaints
(Product Quality, Technical), Document Management, Exception Management
(deviations, nonconformances, OOS, OOT, events), Quality By Design (QbD), Quality Risk
Management, Root Cause/Failure Mode Analysis Tools, Statistical Process Control (SPC),
Supplier Collaboration, Supplier Quality Management (contract services - CMOs, CROs,
etc..), Training Management, PLM, Service Management, IoT, Regulatory Management
(REACH/RoHS, Conflict Minerals, etc.), UDI Management, Requirements Management,
Software Management, Manufacturing Process Management, Reliability and Safety
Management, Systems Engineering, CAD/CAM/CAE
FDA 21 Part 11 Compliant: Yes
License Type: On-Premise, SaaS (single tenant), SaaS (multi-tenant), 3rd Party Hosted
PTC delivers technology solutions that transform the way you create and service products; cutting costs, reducing
risk, and driving growth. Serving 6 continents and over 28,000 customers. PTC is an award winning leader in the
Internet of Things.