SAP Document Compliance

for the Life Science Industry

Robert L. Bruns
David Salamanek
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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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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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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SEAL Systems Solutions

DMS Loader View Server

SAP Conversions Print Management
Digital Signatures

Business Process Collect & Distribute:

PP
PP Production Planning
MM
MM Materials Management
SD
SD Sales & Distribution
PM
PM Plant Maintenance

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DMS Loader Features

Automated DIR creation

SAP batch enabled transaction with retry

Check-in of files & metadata

with validation
validation
on status
status change
change

Creation of classifications
object
object links
links
document
document structures
structures
material
material links
links

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DMS Loader Advantages

Optimized loading Extended logging Subsequent retries

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SAP Conversion Features

PDF is the FDA recommended long term format

Source formats include:
MS
MS Office
Office (doc, xls, ppt, mpp, frm…)
CAD
CAD (ACAD, PROE, UG, CATIA, Inventor…)
Vector
Vector (CGM, HPGL, CALS…)
Raster
Raster (GIF, JPG, PNG…) +++
+++

Target formats of PDF, PDF/A, TIFF

Integration direct to SAP conversion framework
or via
via BC-XDC
BC-XDC
add-on stamps
stamps and
and watermarks
watermarks
add-on title
title block/property
block/property updates
updates
triggered via
via status
status change
change or
or BADI
BADI
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SAP Conversion Advantages

Support FDA certifications Automated process

ISO archive format Conversion workflow
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Digital Signatures Features
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viewing
viewing
printing
printing
converting
converting
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automated creation via SAP conversion server functions
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SAP Smart Forms enabled
append signature page at conversion to PDF
SEAL Systems DPF technology

Dynamic
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automated during distribution process (view/print)
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Digital Signatures Advantages

Support FDA certifications Automated process

Standardized process Customizable
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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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SAP View Server Advantages

Server based solution Document control

Optimized stamp functions
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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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Controlled Printing Advantages

Security stamps & watermarks Auditable distribution

Dynamic stamps for QA Integrated to DMS
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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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Business Process Printing Advantages

Sequenced with shop papers Stamping functions

Signature pages Auditability ERP/DMS security
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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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 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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