Digital Signature ESig

7/17/2019 Digital Signature ESig

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Using Digital Signatures in S P QM

to Meet Regulatory Requirements

Carl Dunlap

Cohesion, Inc.

[email protected]

mailto:[email protected]

mailto:[email protected]



Learning Points

• Understand the concept of Electronic Signatures andCompliance 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 andsignatures 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 andsignatures 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 inSAP 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 pr ior no tice, 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 p rior no tice, and are in no way binding upon SAP.



Customizing for Digital Signature in Notifications I




Customizing for Digital Signatures in Notifications II

The signature can be

activated for

Notif ication type and

business transaction

For header or task level

Synchronously or

asynchronously

With strategy

assignment

Open for all noti fication categories (e.g. QM or PM notifications)!




Signature Process Within Notifications

Example: Step “Put notification into process”


N N tifi ti St t



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 sli de 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 statuschange at notification

header level or task

level

• Performing an activityvia 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

A l “N ” Di it l Si t ithi QM



Apply “New” Digital Signature within QM

• Business Goal

• For inspection lots and physical samples the “new” digitalsignature 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 andusage decision

• New application for multi-level signatures (for inspection results)


G l R k Di it l Si t



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

Central Customizing



Central Customizing

• Within IMG select

• Quality Management =>Environment => CentralFunctions => SignatureStrategy …

• Start with definition of Authorization Group=> define individualsignature and assignauthorization group=> define signature strategyincluding several single

signatures, if required• Define when signature shall

be applied (lot/sample)

DISCLAIMER: This sli de reflects current development. Contents may be changed without p rior notice, and are in no way binding upon SAP.

D fi A th i ti G



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 p rior no tice, 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 p rior no tice, and are in no way binding upon SAP.

A ti t Di it l Si t f S ifi P



Activate Digital Signature for Specific Process

Step f ive:

• Activate signature for

distinct process(es)(*)

(*) Separate customizing for notif ications

DISCLAIMER: This sli de reflects current development. Contents may be changed without p rior notice, and are in no way binding upon SAP.

Prepare Master Data



Prepare Master Data• Assign

Authorization Groupwithin MaterialMaster, QM View

* For lots and samples the activation is done via the material master,

i.e. no material master => no digital signatureDISCLAIMER: This slide reflects current development. Contents may be changed without pr ior no tice, and are in no way binding upon SAP.

Prepare Master Data

Di it l Si t Withi th S l R i t ti



Digital Signature Within the Sample Registration

• As before with individual signature only, but more

fields for documentation available …


Digital Signature Within Results Recording



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 process

Also here with different users (according to signature strategy)


Results Recording: Characteristic Overview



Results Recording: Characteristic Overview

Indicates the actual statusof the digital signature process


Digital Signature on Characteristic Completion



Digital Signature on CharacteristicCompletion

Request signature on characteristic completionDISCLAIMER: This slide reflects current development. Contents may be changed without p rior no tice, and are in no way binding upon SAP.

Digital Signature on Characteristic Completion

Work List for Digital Signatures for Results



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



Visualization of Signature Status in Work List (QE51N) I

• Signature process

started

Signature Details


Visualization of Signature Status in Work List (QE51N) II



Visualization of Signature Status inWork List (QE51N) II

Signature process completeDISCLAIMER: This slide reflects current development. Contents may be changed without pr ior no tice, and are in no way binding upon SAP.

Visualization of Signature Status in Work List (QE51N) II

Related Functions With Signature



Related Functions With Signature

Document to

be signed

History Cancel signature

process

Comment


Digital Signature Within Usage Decision



g ta S g atu e t Usage ec s o

“ New” signature but without strategy (only one level)


Detailed Signature Information Within UD



Detailed Signature Information Within UD


• Navigation into

detailed

signature

information• (at char. level)

Printout of Signature Information



g

• Information from

digital signatures

for a lot can also

be printed in theresults report.

⇒

New parameter

in report.

⇒

Adjustments inrelated forms to

be done (new

work areas

available).


Example Results Printout With Signature



Example Results Printout With Signature

• With signature

information

(according todesign of form)


Central Function To View Signatures



g

• Transaction DSALdisplays the log

from digital

signatures

application-related

DISCLAIMER: This slide reflects current development. Contents may be changed without pr ior noti ce, 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

Pragmaticmethodology

Proven

preconfiguration

Extensive

documentation

SAPBest 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

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

http://help.sap.com/

http://help.sap.com/

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





3706

Session Code:

Digital Signature ESig

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