Weitere ähnliche Inhalte Ähnlich wie Implementing an effective Electronic CAPA Management System (20) Kürzlich hochgeladen (20) Implementing an effective Electronic CAPA Management System1. Implementing an effective Electronic CAPA
Management System
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
2. Gael Ltd – Leaders in Quality
Thought leaders in the world of Quality,
Compliance, Control and Audit
Founded in 1992
100+ employees
+600 Healthcare & Life Science
Clients
Strong Customer Service ethos
Deloitte Fast 500 Growth company
(25%+ growth year on year)
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
3. Today’s objective
Regulatory requirements for CAPA
Elements of effective CAPA
systems
How and why your CAPA
processes should integrate with
other compliance activities
Benefits of implementing an
electronic CAPA management
system 'v' a manual one
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
4. The Reasons
Help Achieve an Organisation’s
Objectives
Address Uncertainty
Support Correct Decision
Making
Drive Performance
Improvement
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
5. The Challenges – Staff Buy In
Under used systems
Not user friendly
No obvious benefit to user
Poor communication and feedback loop
Lack of awareness
No consistency
Must be top down approach led by
management
Culture shift – feed the CAPA system
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
6. The Challenges - Visibility
All control points flow through CAPA system
Deviations / NCRs
Audit Findings
Equipment monitoring
Staff Training
Change Control
OOS
Complaints
Product recalls / returns
Adverse events
Management Review
Managing the ripple effect across all areas is
problematic and difficult to maintain
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
7. The Challenges - Regulatory
21 CFR 820.100 Corrective and Preventive Action
'Establish a CAPA Procedure'
'Analyse with statistical methodology sources of quality data to identify
sources of quality programmes'
ISO 13485 8.5.2 Corrective Action
Organisation shall take action to eliminate the cause of nonconformities to
prevent recurrence
The corrective action shall be appropriate to the level of the effects of the
non-conformance
ISO 13485 8.5.3 Preventive Action
Organisation shall take action to eliminate the cause of nonconformities to
prevent occurrence
The preventive action shall be appropriate to the effects of the non-
conformance
21 CFR Part 11 Guidelines
Electronic Signatures
Full Audit Trails
Intruder Lock-out
Strong Passwords
Electronic Systems Validation
IQ / OQ / PQ
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
8. The Challenges - Regulatory
MHRA’s top 3 QMS related deficiencies
Incomplete or tardy recording and investigation of complaints and
incidents
No regular review of quality indicators
Lack of quality improvement / CAPA processes
FDA Warning Letters 2012
CAPA subsystem cited in 81 0f 89 FDA warding letters (91%)
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
9. Common Scenarios
Paper Based Systems
Paper based reporting forms
Information held in silos
Manual intervention
Internally Developed Systems
Minimal development and support
Hybrid systems
Departmentalised
Lack of regulatory Control
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
10. Possible Solution
An effective solution should provide
Accountability
Analytical intelligence
Encouragement to appropriate people
Simple event capture
Simple reporting
Effective notification
Reduction in risk
How does Q-Pulse do it?
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
12. Some of our customers …
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
13. Typical Standards
ISO 9001
ISO 13485
FDA’s 21 CFR Part 820
FDA’s 21 CFR Part 11
EU GMP Annex 11
CPA / CAP / CLIA
AABB / BSQR
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
14. What our Customers are saying
“Putting Q-Pulse into place has changed the way we work considerably by
providing us with a very user-friendly system that will ensure we can
continue to meet our regulatory requirements and improve our services.
Having all the information stored centrally allows easier and more efficient
access for staff, management, and enables us to demonstrate our quality
control mechanisms to external regulators”
Dr Jennifer Cauchi, Quality Manager at BMDI Cord Blood Bank
“We primarily sought out Q-Pulse to manage document control, but then
we discovered its CA/PA, Asset and Training capabilities and were hooked.”
Andrew Havens, Quality Assurance Manager, University of Utah Cell Therapy Facility
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
15. What our Customers are saying
“Internal and external inspections are critical to our activities,
and the Q-Pulse Audit module helps us manage these activities
and link any subsequent actions to the CA/PA module. Q-Pulse
makes it easier to achieve compliance with our standards and
regulations, providing us with the tools to implement simpler
methods and processes to manage quality.”
Kevin Bruce, Quality Manager at Roslin Cells, Edinburgh
“Q-Pulse gives us a centralized way of managing our QMS
documents and records, including all of our SOPs, in line
with the record-keeping requirements of the FDA”
Marilyn Jeffers, Quality Assurance Manager, Blood Bank of Alaska
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
16. Summary
Regulatory requirements for CAPA
Elements of effective CAPA systems
How and why your CAPA processes should
integrate with other compliance activities
Benefits of implementing an electronic
CAPA management system 'v' a manual
one
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
17. 4 Benefits of Adopting an Integrated
Approach to CA PA Management
Gain company-wide commitment
Ensure competency of appropriate staff
Integrate root cause analysis into quality
systems
Reinforce learning
Download from
gaelquality.com now
Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.