SAP Document Compliance for the Life Sciences Industry

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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 …

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

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  • 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) 25.11.2003 2
  • 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 25.11.2003 3
  • 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 25.11.2003 4
  • 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 25.11.2003 5
  • 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 25.11.2003 6
  • 7. DMS Loader Advantages Optimized loading Extended logging Subsequent retries 25.11.2003 7
  • 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 25.11.2003 8
  • 9. SAP Conversion Advantages Support FDA certifications Automated process ISO archive format Conversion workflow 25.11.2003 9
  • 10. 10 Åáááá Åáááá Å Å ÅÅ ÅÅ çááááààààxxxx çááááààààxxxx automated creation via SAP conversion server functions ç ç fç ç fç ç tf tf tf tf tf tf xxtÄÄÄÄ xxtÄÄÄÄ Signatures on demand with these operations: automated during distribution process (view/print) fxx fxx f f f f f f Åáááá ÅÅ Å çááááààààxxxx append signature page at conversion to PDF çç ç tf tf tf f xxtÄÄÄÄ fxx f f f Åáááá Åáááá Å Å ÅÅ ÅÅ çááááààààxxxx çááááààààxxxx ç ç fç ç fç ç SEAL Systems DPF technology tf tf tf tf tf tf xxtÄÄÄÄ xxtÄÄÄÄ fxx fxx SAP Smart Forms enabled f f f f f f Åáááá ÅÅ Å çááááààààxxxx çç ç tf tf tf f xxtÄÄÄÄ fxx f f f Åáááá Åáááá converting ÅÅ ÅÅ converting Å Å çááááààààxxxx çááááààààxxxx çç çç ç ç printing viewing printing viewing Digital Signatures Features tf tf tf tf tf f tf f xxtÄÄÄÄ xxtÄÄÄÄ fxx fxx f f f f f f Åáááá Dynamic ÅÅ Å çááááààààxxxx çç ç Static tf tf tf f xxtÄÄÄÄ fxx f f f Åáááá Åáááá ÅÅ ÅÅ Å Å çááááààààxxxx çááááààààxxxx çç çç ç ç 25.11.2003 tf tf tf tf tf f tf f xxtÄÄÄÄ xxtÄÄÄÄ fxx fxx f f f f f f
  • 11. Digital Signatures Advantages Support FDA certifications Automated process Standardized process Customizable 25.11.2003 11
  • 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 f|z f|z 25.11.2003 12
  • 13. SAP View Server Advantages Server based solution Document control Optimized stamp functions 25.11.2003 13
  • 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 f|z f|z 25.11.2003 14
  • 15. Controlled Printing Advantages Security stamps & watermarks Auditable distribution Dynamic stamps for QA Integrated to DMS 25.11.2003 15
  • 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 25.11.2003 16
  • 17. Business Process Printing Advantages Sequenced with shop papers Stamping functions Signature pages Auditability ERP/DMS security 25.11.2003 17
  • 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 f|z f|z 25.11.2003 18
  • 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 25.11.2003 19