SAP Document Compliance

for the Life Science Industry

SAP Document Compliance

for the Life Science Industry

Robert L. Bruns

David Salamanek

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)

25.11.2003 3

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

25.11.2003 4

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

25.11.2003 5

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)

25.11.2003 11

Digital Signatures Advantages

Automated processAutomated process

Standardized processStandardized process CustomizableCustomizable

Support FDA certificationsSupport FDA certifications

25.11.2003 12

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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25.11.2003 13

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

25.11.2003 15

Controlled Printing Advantages

Auditable distributionAuditable distribution

Dynamic stamps for QADynamic stamps for QA Integrated to DMSIntegrated to DMS

Security stamps & watermarksSecurity stamps & watermarks

25.11.2003 16

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

25.11.2003 17

Business Process Printing Advantages

Stamping functionsStamping functions

Signature pagesSignature pages AuditabilityAuditability

Sequenced with shop papersSequenced with shop papers

ERP/DMS securityERP/DMS security

25.11.2003 18

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

25.11.2003 19

www.sealsystems.com

Product Information

Demos

White Papers

ROI Spreadsheet

Robert Bruns

865 380 0005bob.bruns@sealsystems.com

David Salamanek

602 476 2347david.salamanek@sealsystems.com

Thank you for your time!