Digital Signatures in SolMan 7.1 Web UIfor

ChaRM Approvals

• SolMan 7.1 / CRM 7.0 Web UI• Part 11 Compliant• Part 11 Compliant• Audit Log

SAP Solution BriefSAP Solution Brief

Index

Synopsis11

IT Sapiens’ Solution Features22

Solution (Screen shots)33

Solution Merits44

Our Value Proposition55

1Questions ?66

June 6th 2014 ©2014 IT Sapiens, Inc. Proprietary and Confidential

Synopsis11

Standard SolMan 7.1 ChaRM (Change Request Management) in Web UI: ChaRM Functionality in SolMan 7.1 (i.e. CRM 7.0) is all Web UI based (as

opposed to SolMan 7.0 which is ABAP GUI based) Does not provide for an ability to execute Part 11 Compliant Digital Signatures

during ChaRM Approvals and Status Changes, and provide for its related Audit Logs

Lack of Part 11 Compliant Digital Signatures during ChaRM Approvals functionality, has caused Life Sciences, Pharma, Food and Beverage Companies (i.e. the FDA and GxP standards regulated industry segments) to not willingly embrace the benefits of using SolMan ChaRM in 7.0 / 7,1 versions

Customers have incorporated offline work around processes to overcome this GAP (e.g. attaching email approvals into the ChaRM Transactions)

Requires fair amount of custom development (BSP Component, GENIL / BOL and ABAP Development) to bridge the aforesaid GAP

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IT Sapiens’ Solution Features22

Using “Creative Configurations” IT Sapiens has developed the Digital Signatures in SolMan 7.1 / CRM 7.0 Web UI for ChaRM Approvals and StatusChanges: Digital Signature prompt triggered upon “Save” of Approval or Status Change

Part 11 Compliant User ID Required and Changeable Password Required Comment Specification Required

Consistency Checks during Status Change of ChaRM document/Transaction prevents Status Change of ChaRM Document if: User ID is invalid Password in invalid C t t ifi d Comment not specified User cancels or manually closes Digital signature prompt

Digital Signature record is logged b t i d t t dit i f i dl h i

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can be retrieved to support an audit, using a user friendly comprehensive report

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IT Sapiens’ Solution Features22

Digital Signatures in Web UI for ChaRM Approvals and Status Changes: Digital signature prompt (popup) in Web UI is comprehensive and has all fields

similar to that of the ABAP GUI based prompt (see comparison below) ABAP GUI based prompt:

Web UI based Digital signature prompt: Title shows Doc #

Mandatory fields

Mandatory fields

Mandatory fields

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IT Sapiens’ Solution Features22

Digital Signatures in Web UI for ChaRM Approvals and Status Changes: Change Request Processing (*MCR)

Digital Signature prompt triggered from PPF Actions and Approval Block: During “Global Approval” (if Global/Regional Impact = “Global”) During “Business Approval” During “Change Manager Approval” Extendable to any Action

Urgent Change Processing (*MHF) Digital Signature prompt triggered from PPF Actions:

D i St t h t “D l t C l t ” ( b F ti l During Status change to “Development Complete” (e.g. by Functional Lead or Configuration Lead/Manager)

During action “Approval to Promote to QA” (e.g. by QA/Validation Lead) D i St t h t “T ti V lid t d” ( i t A i UAT) During Status change to “Testing Validated” (e.g. prior to Approving UAT) During Status change to “Successfully Tested” (e.g. by QA/Validation

Lead) During Status change to “Authorized for Production” (e g by Release

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During Status change to Authorized for Production (e.g. by Release Manager)

Extendable to any ActionJune 6th 2014 ©2014 IT Sapiens, Inc. Proprietary and Confidential

IT Sapiens’ Solution Features22

Digital Signatures in Web UI for ChaRM Approvals and Status Changes: Normal Change Processing (*MMJ)

Digital Signature prompt triggered from PPF Actions: During Status change to “Development Complete” (e.g. by Functional

Lead or Configuration Lead/Manager) During Status change to “Preliminary Import Requested” (e.g. Functional

Lead or Configuration Lead/Manager or Change Manager) During Status change to “Testing Validated” (e.g. prior to Approving UAT) During Status change to “Successfully Tested” (e.g. by QA/Validation

L d)Lead) During Status change to “Released for Import” (e.g. by Release Manager) Extendable to any Action

Ad i i t ti Ch P i (*MAD) Administrative Change Processing (*MAD) Digital Signature prompt triggered from PPF Actions:

During Status change to “Completed” (e.g. by System Admin Lead) During Status change to “Completed” (e g by QA/Validation Lead)

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During Status change to Completed (e.g. by QA/Validation Lead) Extendable to any CRM Service Process Transaction Type

June 6th 2014 ©2014 IT Sapiens, Inc. Proprietary and Confidential

Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: Approval / Status Change Action Execution

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: Action “Global Approve-Change Request” executed

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: Upon Saving, Digital Signature Prompt appears User accepts default User ID (or changes

User ID to the approver’s User ID), Password and Comment (all of which are mandatory fields)

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: Users clicks on “Cancel” button, instead of “Continue” button (expected result is

Status should NOT change to “Global Approved”)

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: On “Cancel” button Status change does not occur and message “Status reset by

system appears” (Similar result occurs if User closes window too)

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: User re-executes action with clicking on “Continue” button “User ID”, “Password”,

“Comment exists” is validated and if all is well, status change occurs and log is updated

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: User re-executes action with clicking on “Continue” button “User ID”, “Password”,

“Comment exists” is validated and if all is well, status change occurs & log is updated

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Solution – Digital Signature in “Change Request”33

Sample of Digital Signature in Change Request Processing: Digital Signature Log shows Change Request has been successfully signed

Comments Long textComments Long textLong textLong text

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Solution – Digital Signature in “Urgent Change”33

Sample of Digital Signature in Urgent Change Processing: Action “Set to Development Complete” prompts for digital signature upon “Save” user accepts User ID, specifies password & comment clicks on “Continue” Status changes to “Development Complete”

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Solution – Digital Signature in “Urgent Change”33

Sample of Digital Signature in Urgent Change Processing: Action “Approval to Promote to QA ” prompts for digital signature upon “Save”

user accepts User ID, specifies password & comment clicks on “Continue” Status changes to “To Be Tested”

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Solution – Digital Signature in “Urgent Change”33

Sample of Digital Signature in Urgent Change Processing: Action “Confirm Successful Test” prompts for digital signature upon “Save”

user accepts User ID, specifies password & comment clicks on “Continue” Status changes to “Successfully Tested”

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Solution – Digital Signature in “Urgent Change”33

Sample of Digital Signature in Urgent Change Processing: Action “Release Urgent Change for Production ” prompts for digital signature

upon “Save” user accepts User ID, specifies password & comment clicks on “Continue” Status changes to “Authorized for Production”

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Solution – ChaRM Digital Signatures Audit Log33

ChaRM Digital Signatures Audit Log: Shows Digital Signature Time Stamp, Comments, etc.

The image cannot be displayed. Your computer may not have enough memory to open the image, or the image may have been corrupted. Restart your computer, and then open the file again. If the red x still appears, you may have to delete the image and then insert it again.

Comments Long text

Comments Long text

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Solution Merits44

Digital Signatures in Web UI for ChaRM Approvals and Status Changes: Robust and built on SAP ChaRM framework with adherence to “Post Processing

Framework” and “Consistency Checks” Built on SAP Digital Signature framework of Strategies, Authorizations, etc. Look and feel is similar to that of ABAP GUI “SAP ECC based Digital Signatures” or

“SAP SolMan 7.0/7.1 based Document Signatures” or “SAP SolMan 7.0 based ChaRM Digital” (which is also an IT Sapiens’ solution)

Leverages SAP Standard Configuration and User Exits. NO SOURCE CODE MODIFICATIONS. Solution is UPGRADE COMPLIANT.

Digital Signature Prompt built as a Standalone Component that can be leveraged for any CRM Service Process Transaction Type

Is 21 CFR Part 11 compliant and meets requirements of “FDA” and “GxP” regulated t d dstandards

“Best suited” and “Off the Shelf” Solution for all Life Sciences, Pharma, Consumer, Food and Beverages industry (i.e. the FDA and GxP standards regulated industry segments)

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segments) Implementation (Time to Benefit), either onsite or remotely, in 2-3 weeks

June 6th 2014 ©2014 IT Sapiens, Inc. Proprietary and Confidential

Our Value Proposition55

Reduced TCO, Highest First Pass Yield and Highest Quality from: Strong expertise in providing end-to-end Supply Chain and ALM Solutions Strong Expertise implementing SAP, enriching Business processes and

alleviating GAPs in SAP, for Life Sciences, Consumer Products, Chemical and High-Tech Industry segments (i.e. the FDA and GxP standards regulated industry segments) dus y seg e s)

Sound understanding of ITIL standards, GxP and 21 CFR Part 11 regulations Very experienced consulting resource base with 12+ years experience and

deep cross-functional expertisedeep cross functional expertise Rich Knowledge base of custom solutions to address GAPs in most SAP

applications Ability to demonstrate end state on Day 1 using in house SAP Systems rich Ability to demonstrate end-state on Day 1 using in-house SAP Systems rich

with: Pre-configured Solutions demo able SAP Functionality Demo able IT Sapiens custom solutions

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demo-able SAP Functionality, Demo-able IT Sapiens custom solutions Framework to develop strawman solutions

Our “Say-To Do” Ratio is 1:1June 6th 2014 ©2014 IT Sapiens, Inc. Proprietary and Confidential

Questions ?66

For more information…kindly contact

Vijay PisipatyDirector-ERP Solutions & ConsultingIT Sapiens, Inc.e-mail: vijay.pisipaty@itsapiens.com

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