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Dunlap 3706 e_sig
- 1. Using Digital Signaturesin SAP QM to Meet Regulatory Requirements Carl Dunlap Cohesion, Inc. cdunlap@cohesion.biz
- 2. Learning Points • Understandthe concept of Electronic Signatures and Compliance issues • Discover how SAP software uses Digital Signatures to meet regulatory requirements • Get a look at upcoming additional functionality in ERP 2005 to satisfy signature requirements
- 3. What is Part11? • Regulation allowing FDA to accept electronic records and signatures in place of paper records and handwritten signatures • Describes controls to ensure that electronic records and signatures are: • Trustworthy • Reliable • Compatible with FDA work • Effective August 20, 1997 http://www.fda.gov/cder/regulatory/ersr/2002_11_05_standards1/sld003.htm • Regulation allowing FDA to accept electronic records and signatures in place of paper records and handwritten signatures • Describes controls to ensure that electronic records and signatures are: • Trustworthy • Reliable • Compatible with FDA work
- 4. Digital Signature inResults Recording
- 5. Digital Signature atUsage Decision
- 6. Digital Signature inPI Sheet
- 7. Digital Signature Quality Notification- using Business Add In
- 8. New Digital SignatureFunctionality in SAP QM SAP ERP 2005, with Enhancement Package 3 *scheduled Nov. 2007 • Modern Signature Tool • Signature Strategies • Sequences • Settings for Comments (optional, mandatory, etc.) • Signature for Quality Notification is now standard • Header, Tasks, Action Box • Inspection Lots • Document Business Data with Signature * Subject to Change DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 9. New Digital Signaturefor Lots and Samples Digital Signature for Notifications
- 10. Digital Signature ForNotifications Business Goal • When processing a notification within mySAP ERP, digital signatures are required for distinct steps. It shall be possible to provide them with status change and when performing distinct activities at header or task level. Also signature strategies shall be allowed. Solution • New customizing functions for notifications • New functions during notification processing DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 11. Customizing for DigitalSignature in Notifications I DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 12. Customizing for DigitalSignatures in Notifications II The signature can be activated for Notification type and business transaction For header or task level Synchronously or asynchronously With strategy assignment Open for all notification categories (e.g. QM or PM notifications)! DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 13. Signature Process WithinNotifications Example: Step “Put notification into process” DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 14. New Notification Status •New system status in the notification indicate the signature status: • DSAC Digital Signature Process active • DSCL Digital Signature Process completed DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 15. What is Signedin the Notification? Important! • The signature is given for a business process and not for distinct notification content (*). • It can be requested when … • Performing a status change at notification header level or task level • Performing an activity via the action box (*) Technically this means: the signature data does not contain any data table content, such as from QMEL. DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 16. Viewing Signature toa Particular Notification DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 17. New Digital Signaturefor Lots and Samples Digital Signature for Notifications
- 18. Apply “New” DigitalSignature within QM • Business Goal • For inspection lots and physical samples the “new” digital signature technology shall be applied in order to allow … • Signature strategies • Multi-level signatures • A more detailed documentation • Printout of signature information • Solution • Extended customizing • New functions during sample registration, results recording and usage decision • New application for multi-level signatures (for inspection results) DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 19. General Remarks re:Digital Signature • Digital signatures … Are part of an approval procedure Ensuring that only authorized people can influence how the process continues To fulfill security requirements according to Good Manufacturing Practices (GMP) • Signature Methods Provided by SAP • System signature with authorization by user ID and password • User signature with/without verification • Individual signatures as sub-steps of a signature strategy in order to sign different process steps in a distinct sequence. Predecessor signatures Signatures to be executed S1 S2 S3 S1 S2 X S3 X X
- 20. Central Customizing • WithinIMG select • Quality Management => Environment => Central Functions => Signature Strategy … • Start with definition of Authorization Group => define individual signature and assign authorization group => define signature strategy including several single signatures, if required • Define when signature shall be applied (lot/sample) DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 21. Define Authorization Groups DISCLAIMER:This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. Step one: • Define authorization group for digital signature
- 22. Define Individual Signatures Steptwo: • Define individual signatures for signature strategies DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 23. Bundle Individual Signaturesto a Strategy Step three: • Bundle individual signatures DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 24. Define Sequence ofSignatures Step four: Define required sequence in a strategy DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 25. Activate Digital Signaturefor Specific Process Step five: • Activate signature for distinct process(es)(*) (*) Separate customizing for notifications DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 26. Prepare Master Data •Assign Authorization Group within Material Master, QM View * For lots and samples the activation is done via the material master, i.e. no material master => no digital signature DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. Prepare Master Data
- 27. Digital Signature Withinthe Sample Registration • As before with individual signature only, but more fields for documentation available … DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 28. Digital Signature WithinResults Recording Adjustments • Actual signature status displayed in separate column within characteristic overview and Work list tree (QE51N) • Signature strategy with several individual signatures possible • First “completion” only sets status 3 for a characteristic => further completion via separate transaction to cover additional signatures • It is possible to cancel the signature process Also here with different users (according to signature strategy) DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 29. Results Recording: CharacteristicOverview Indicates the actual status of the digital signature process DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 30. Digital Signature onCharacteristic Completion Request signature on characteristic completion DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. Digital Signature on Characteristic Completion
- 31. Work List forDigital Signatures for Results • New transaction QEDS to proceed after first signature if signature strategy is used 1 2 DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. 3 New transaction: QEDS
- 32. Visualization of SignatureStatus in Work List (QE51N) I • Signature process started Signature Details DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 33. Visualization of SignatureStatus in Work List (QE51N) II Signature process complete DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. Visualization of Signature Status in Work List (QE51N) II
- 34. Related Functions WithSignature Document to be signed History Cancel signature process Comment DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 35. Digital Signature WithinUsage Decision “New” signature but without strategy (only one level) DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 36. Detailed Signature InformationWithin UD DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP. • Navigation into detailed signature information • (at char. level)
- 37. Printout of SignatureInformation • Information from digital signatures for a lot can also be printed in the results report. ⇒ New parameter in report. ⇒ Adjustments in related forms to be done (new work areas available). DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 38. Example Results PrintoutWith Signature • With signature information (according to design of form) DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 39. Central Function ToView Signatures • Transaction DSAL displays the log from digital signatures application-related DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
- 40. Best Practices • Takeadvantage of SAP Best Practices • Go live quickly with SAP All-in-One Time Risk Pragmatic methodology Proven preconfiguration Extensive documentation SAP Best Practices Cost
- 41. Key Learnings • Startwith simple signature using SAP user ID and password • Utilize SAP “internal controls” • Set aside time for documentation and validation • Test, Test, Test
- 42. Return on Investment •No separate investments in outside software (i.e. LIMS) needed • Cost of storing paper records • “Cost of Compliance”
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