The Life Sciences industry has strict requirements surrounding document processing and control. This PDF describes the challenges of document manipulation and distribution for many operating facets for the industry

1. SAP Document Compliance
for the Life Science Industry
Robert L. Bruns
David Salamanek

2. Introduction
SEAL Systems solutions are SAP certified
More than 10 years experience with SAP
Global locations for consulting and support
500 installations world-wide
(Life Technologies)
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3. Current State of the Industry
Tightened regulations for new products
Extended restrictions regulating employees
Millions of dollars more spent on R&D
Legal costs increased due to regulations
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4. SAP and the Pharmaceutical Industry
SAP and Life Sciences together for 30 years
Over 1,500 expert installations for the Industry
Regulatory compliance in the following:
MM QM Batch & Unit Mgmt
PM SD Document Mgmt
PP LE ECM
PP-PI EH&S Auditing
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5. SEAL Systems Solutions
DMS Loader View Server
SAP Conversions Print Management
Digital Signatures
Business Process Collect & Distribute:
PP Production Planning
PP
MM Materials Management
MM
SD Sales & Distribution
SD
PM Plant Maintenance
PM
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6. DMS Loader Features
Automated DIR creation
SAP batch enabled transaction with retry
Check-in of files & metadata
with validation
validation
on status change
status change
Creation of classifications
object links
object links
document structures
document structures
material links
material links
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7. DMS Loader Advantages
Optimized loading Extended logging Subsequent retries
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8. SAP Conversion Features
PDF is the FDA recommended long term format
Source formats include:
MS Office (doc, xls, ppt, mpp, frm…)
MS Office
CAD (ACAD, PROE, UG, CATIA, Inventor…)
CAD
Vector (CGM, HPGL, CALS…)
Vector
Raster (GIF, JPG, PNG…) +++
Raster +++
Target formats of PDF, PDF/A, TIFF
Integration direct to SAP conversion framework
or via BC-XDC
via BC-XDC
add-on stamps and watermarks
stamps and watermarks
add-on title block/property updates
title block/property updates
triggered via status change or BADI
via status change or BADI
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9. SAP Conversion Advantages
Support FDA certifications Automated process
ISO archive format Conversion workflow
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11. Digital Signatures Advantages
Support FDA certifications Automated process
Standardized process Customizable
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12. SAP View Server Features
Stamp before view for PDF
Server side processing
Configurable & secure watermarks & stamps
Easy to customize layouts
Configurable content with DMS metadata
Automated signature page addition
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13. SAP View Server Advantages
Server based solution Document control
Optimized stamp functions
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14. Controlled Printing Features
Direct print from SAP DMS records
Single documents & document sets
With stamps & watermarks
Customizable receiver & distribution profiles
Document distribution with SAP accounts
Automated signature, title & page numbers
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15. Controlled Printing Advantages
Security stamps & watermarks Auditable distribution
Dynamic stamps for QA Integrated to DMS
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16. Business Process Printing Features
All DMS documents from these SAP processes:
PP PM SD
MM BOM DSA
SAP Script, Smart Forms, Adobe Forms
Includes all control information
Printed or electronically distributed
Fully sequenced based in standard SAP transactions
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17. Business Process Printing Advantages
Sequenced with shop papers Stamping functions
Signature pages Auditability ERP/DMS security
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18. Conclusion
SEAL Systems offers a complete solution portfolio
Manages many compliance requirements
SAP certified solutions for the entire enterprise
Consulting & implementation competency
Well established company
Save time, effort & resources
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19. Thank you for your time!
www.sealsystems.com
Product Information
Demos
White Papers
ROI Spreadsheet
Robert Bruns
865 380 0005
bob.bruns@sealsystems.com
David Salamanek
602 476 2347
david.salamanek@sealsystems.com
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