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Using Digital Signatures in SAP QM to Meet Regulatory RequirementsCarl DunlapCohesion, Inc.
cdunlap@cohesion.biz
Learning Points• Understand the 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
What is Part 11?• 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
Digital Signature in Results Recording
Digital Signature at Usage Decision
Digital Signature in PI Sheet
Digital Signature Quality Notification - using Business Add In
New Digital Signature Functionality in SAP QMSAP 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.
New Digital Signature for Lots and Samples
Digital Signature for Notifications
Digital Signature For Notifications
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.
Customizing for Digital Signature in Notifications I
DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
Customizing for Digital Signatures in Notifications II
The signature can be activated for
Notification type andbusiness transaction
For header or task level
Synchronously or asynchronously
With strategyassignment
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.
Signature Process Within Notifications
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.
New Notification Status
• New system status in the notification indicate the signature status:
• DSACDigital Signature Process active
• DSCLDigital Signature Process completed
DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
What is Signed in 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.
Viewing Signature to a Particular Notification
DISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
New Digital Signature for Lots and Samples
Digital Signature for Notifications
Apply “New” Digital Signature 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.
General Remarks re: Digital Signature
• Digital signatures …Are part of an approval procedureEnsuring 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 signaturesSignatures to be executed
S1 S2 S3 S1 S2 X S3 X X
Central Customizing
• Within IMG 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.
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
Define Individual Signatures
Step two:• 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.
Bundle Individual Signatures to a Strategy
Step three:• Bundle individual
signaturesDISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
Define Sequence of Signatures
Step four: Define required sequence in a strategyDISCLAIMER: This slide reflects current development. Contents may be changed without prior notice, and are in no way binding upon SAP.
Activate Digital Signature for 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.
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
Digital Signature Within the 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.
Digital Signature Within Results 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 processAlso 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.
Results Recording: Characteristic Overview
Indicates the actual statusof 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.
Digital Signature on Characteristic Completion
Request signature on characteristic completionDISCLAIMER: 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
Work List for Digital 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
Visualization of Signature Status 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.
Visualization of Signature Status in Work List (QE51N) II
Signature process completeDISCLAIMER: 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
Related Functions With Signature
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.
Digital Signature Within Usage 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.
Detailed Signature Information Within 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)
Printout of Signature Information
• 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.
Example Results Printout With 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.
Central Function To View 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.
Best Practices• Take advantage of SAP Best Practices• Go live quickly with SAP All-in-One
Time Risk
Pragmatic methodology
Proven preconfiguration
Extensive documentation
SAP Best Practices
Cost
Key Learnings• Start with simple signature using SAP user ID and
password • Utilize SAP “internal controls”• Set aside time for documentation and validation• Test, Test, Test
Return on Investment• No separate investments in outside software (i.e. LIMS)
needed• Cost of storing paper records• “Cost of Compliance”
References:• http://searchsap.techtarget.com/searchSAP/downloads/Us
ingDigitalSignaturesEMconvtSearchSAP.pdf
• http://www.fda.gov/cder/guidance/5667fnl.pdf
• http://help.sap.com
3706Session Code:
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