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SAP Document Compliance
for the Life Science Industry
SAP Document Compliance
for the Life Science Industry
Robert L. Bruns
David Salamanek
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25.11.2003 2
Introduction
More than experience with SAP
GlobalGlobal
500500
SEAL Systems solutions are
installations world-wide
locations for consulting and support
10 years10 years
SAP certifiedSAP certified
(Life Technologies)
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Current State of the Industry
Legal costsLegal costs
for new products
increased due to regulations
Tightened regulationsTightened regulations
regulating employeesExtended restrictionsExtended restrictions
MillionsMillions of dollars more spent on R&D
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SAP and the Pharmaceutical Industry
MM
SAP and Life Sciences together for 30 years30 years
expert installations for the IndustryOver 1,500Over 1,500
Regulatory complianceRegulatory compliance in the following:
PM
PP
PP-PI
QM
SD
LE
EH&S
Batch & Unit Mgmt
Document Mgmt
ECM
Auditing
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SEAL Systems Solutions
DMS LoaderDMS Loader
SAP ConversionsSAP Conversions
Digital SignaturesDigital Signatures
View ServerView Server
Print ManagementPrint Management
PPPP
Business Process Collect & Distribute:
MMMM
SDSD
PMPM
Production Planning
Materials Management
Sales & Distribution
Plant Maintenance
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DIR creationAutomatedAutomated
SAP batch enabledbatch enabled transaction with
Check-in of files & metadatafiles & metadata
validationvalidationwith
status changestatus changeon
Creation of classificationsclassifications
object linksobject links
document structuresdocument structures
material linksmaterial links
retryretry
DMS Loader Features
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DMS Loader Advantages
Optimized loadingOptimized loading Extended loggingExtended logging Subsequent retriesSubsequent retries
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SAP Conversion Features
is the FDA recommended long term formatPDFPDF
Source formats include:MS OfficeMS Office (doc, xls, ppt, mpp, frm…)
CADCAD
VectorVector
(ACAD, PROE, UG, CATIA, Inventor…)
(CGM, HPGL, CALS…)
RasterRaster (GIF, JPG, PNG…)
SAP conversion frameworkSAP conversion frameworkIntegration direct to
via BC-XDCvia BC-XDCor
stamps and watermarksstamps and watermarksadd-on
title block/property updatestitle block/property updatesadd-on
via status change or BADIvia status change or BADItriggered
++++++
PDF, PDF/A, TIFFPDF, PDF/A, TIFFTarget formats of
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SAP Conversion Advantages
Automated processAutomated process
ISO archive formatISO archive format Conversion workflowConversion workflow
Support FDA certificationsSupport FDA certifications
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Digital Signatures Features
on demand with these operations:SignaturesSignatures
viewingviewing
printingprinting
convertingconverting
StaticStatic
DynamicDynamic
automated creation via SAP conversion server functions
SAP Smart Forms enabled
append signature page at conversion to PDF
SEAL Systems DPF technology
automated during distribution process (view/print)
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Digital Signatures Advantages
Automated processAutomated process
Standardized processStandardized process CustomizableCustomizable
Support FDA certificationsSupport FDA certifications
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Configurable & secure
SAP View Server Features
watermarks & stampswatermarks & stamps
layoutslayoutsEasy to customize
Server side processingServer side processing
Stamp before viewStamp before view for PDF
DMS metadataDMS metadataConfigurable content with
signature pagesignature pageAutomated addition
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SAP View Server Advantages
Document controlDocument control
Optimized stamp functionsOptimized stamp functions
Server based solutionServer based solution
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Controlled Printing Features
Customizable
SAP accountsSAP accountsDocument distribution with
signature, title & page numberssignature, title & page numbersAutomated
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from SAP DMS records
Single documents & document
Direct printDirect print
setssets
With stamps & watermarksstamps & watermarks
receiver & distribution profilesreceiver & distribution profiles
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Controlled Printing Advantages
Auditable distributionAuditable distribution
Dynamic stamps for QADynamic stamps for QA Integrated to DMSIntegrated to DMS
Security stamps & watermarksSecurity stamps & watermarks
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Printed or electronically
Business Process Printing Features
DMSDMS
PMPM SDSD
BOMBOMMMMM DSADSAPPPP
All documents from these SAP processes:
distributeddistributed
Includes all control informationcontrol information
SAP Script, Smart Forms, Adobe FormsSAP Script, Smart Forms, Adobe Forms
Fully sequenced based in standard SAP transactionsstandard SAP transactions
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Business Process Printing Advantages
Stamping functionsStamping functions
Signature pagesSignature pages AuditabilityAuditability
Sequenced with shop papersSequenced with shop papers
ERP/DMS securityERP/DMS security
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compliance requirementscompliance requirements
Conclusion
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Consulting & implementation
SAP certifiedSAP certified
competencycompetency
SEAL Systems offers a
solutions for the entire enterprise
complete solution portfoliocomplete solution portfolio
Well establishedWell established company
Manages many
Save time, effort & resourcesSave time, effort & resources
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www.sealsystems.com
Product Information
Demos
White Papers
ROI Spreadsheet
Robert Bruns
865 380 [email protected]
David Salamanek
602 476 [email protected]
Thank you for your time!