Using Digital Signatures in SAP QM to Meet Regulatory ...cohesion.biz/home/wp-content/uploads/2013/09/DUNLAP_3706_eSig.pdfUsing Digital Signatures in SAP QM to Meet Regulatory Requirements

Using Digital Signatures in SAP QM to Meet Regulatory RequirementsCarl DunlapCohesion, Inc.

[email protected]

mailto:[email protected]

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

http://www.fda.gov/cder/regulatory/ersr/2002_11_05_standards1/sld003.htm

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


Customizing for Digital Signature in Notifications I


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)!


Signature Process Within Notifications

Example: Step “Put notification into process”


New Notification Status

• New system status in the notification indicate the signature status:

• DSACDigital Signature Process active

• DSCLDigital Signature Process completed


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.


Viewing Signature to a Particular Notification


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)


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)


Define Authorization Groups


Step one:• Define authorization

group for digital signature

Define Individual Signatures

Step two:• Define individual

signatures for signature strategies


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


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


Prepare Master Data

Digital Signature Within the Sample Registration

• As before with individual signature only, but more fields for documentation available …


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)


Results Recording: Characteristic Overview

Indicates the actual statusof the digital signature process


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


3

New transaction: QEDS

Visualization of Signature Status in Work List (QE51N) I

• Signature process started

Signature Details


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


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


• 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).


Example Results Printout With Signature

• With signature information (according to design of form)


Central Function To View Signatures

• Transaction DSAL displays the log from digital signatures application-related


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”

SAP Resources:• http://service.sap.com/lifesciences

http://service.sap.com/lifesciences

References:• http://searchsap.techtarget.com/searchSAP/downloads/Us

ingDigitalSignaturesEMconvtSearchSAP.pdf

• http://www.fda.gov/cder/guidance/5667fnl.pdf

• http://help.sap.com

http://searchsap.techtarget.com/searchSAP/downloads/UsingDigitalSignaturesEMconvtSearchSAP.pdf

http://searchsap.techtarget.com/searchSAP/downloads/UsingDigitalSignaturesEMconvtSearchSAP.pdf

http://www.fda.gov/cder/guidance/5667fnl.pdf

http://help.sap.com/

3706Session Code:

Documents

Using Digital Signatures in SAP QM to Meet Regulatory ...cohesion.biz/home/wp-content/uploads/2013/09/DUNLAP_3706_eSig.pdfUsing Digital Signatures in SAP QM to Meet Regulatory Requirements