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 for the industry

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SAP Document Compliance for the Life Sciences Industry

  1. 1. SAP Document Compliance for the Life Science Industry Robert L. Bruns David Salamanek
  2. 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. 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. 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. 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. 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. 7. DMS Loader Advantages Optimized loading Extended logging Subsequent retries 25.11.2003 7
  8. 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. 9. SAP Conversion Advantages Support FDA certifications Automated process ISO archive format Conversion workflow 25.11.2003 9
  10. 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. 11. Digital Signatures Advantages Support FDA certifications Automated process Standardized process Customizable 25.11.2003 11
  12. 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. 13. SAP View Server Advantages Server based solution Document control Optimized stamp functions 25.11.2003 13
  14. 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. 15. Controlled Printing Advantages Security stamps & watermarks Auditable distribution Dynamic stamps for QA Integrated to DMS 25.11.2003 15
  16. 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. 17. Business Process Printing Advantages Sequenced with shop papers Stamping functions Signature pages Auditability ERP/DMS security 25.11.2003 17
  18. 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. 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

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