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Material Batch Master Change ControlMaterial Batch Master Change Control
• Segregation of Duties
• GxP Compliance• GxP Compliance
Solution BriefSolution Brief
Index
Synopsis11
General Life Sciences Industry Requirements22
’IT Sapiens’ Solution Features33
Solution Demo44
Solution Merits55
Our Value Proposition66
1 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Questions ?77
Our Value Proposition66
Synopsis11
 SAP Standard Functionality:
 SAP Standard Functionality around Material Batch Master:
 Provides ability to maintain the Batch Status “Unrestricted” orProvides ability to maintain the Batch Status Unrestricted or
“Restricted”
 Provides ability to maintain Batch properties using Classification
Class and CharacteristicsClass and Characteristics
 Provides ability to maintain Batch Shelf Life Expiration Date, GR
Date, etc.
 SAP Standard Functionality around Material Batch Master:
 DOES NOT Provide ability to control/restrict Batch Characteristics
maintenance/change by characteristic
 DOES NOT provide ability to control/restrict Batch Shelf Life
Expiration Data and other fields maintenance/change at a field level
 DOES NOT Provide ability to control/restrict Batch Master Data by
2
DOES NOT Provide ability to control/restrict Batch Master Data by
View (e.g. Basic Data 1, Basic Data 2, etc).
June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Material Batch Master Change Control – Requirements22
 Life Sciences Industry Requirements for Batch Master Change Control:
 Need ability to provide access to non-QA and non-QC users to
update/maintain Material Batch Master without risk of changing GxP relatedupdate/maintain Material Batch Master without risk of changing GxP related
fields:
 Need ability to control Batch Characteristics update by Characteristic
 e g No access to update Batch Valuation code Characteristic e.g. No access to update Batch Valuation code Characteristic
 e.g. No access to update Batch Status Characteristic
 e.g. No access to update Batch User Status Characteristic
 e.g. Access to update Tablet Weight Characteristic
 e.g. Access to update DEA Schedule, etc.
 Need ability to control access to Batch Master Basic Data 1 View at a
field level
 Need ability to control access to Batch Master Basic Data 2 View at a
field level
3
field level
(Contd…)
June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
IT Sapiens’ Solution Features33
 Solution Excerpts:
 Custom Authorization and checks incorporated into core SAP Txns MSC1N,
MSC2N without any source code modifications
 Ability to control access to Material Batch Master at View level (e.g. Basic
Data 1, Basic Data 2
 Ability to control access to every field on Batch Master in Txn MSC2NAbility to control access to every field on Batch Master in Txn MSC2N
 e.g. Fields with no access are changed to “Display Only” fields in Txn
MSC2N
 Ability to control access to every Characteristic in Batch Maser in Txn Ability to control access to every Characteristic in Batch Maser in Txn
MSC2N
 e.g. Characteristics with no access are changed to “Display Only”
Characteristics in Txn MSC2N
 Separate Authorization Roles for QA/QC and non-QA/non-QC users that
supports Segregation of Duties and GxP compliance
4 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo – QA/QC User with Unlimited Access44
 Transaction MSC2N (Change Batch):
 All fields on Basic Data 1 View are shown as “Changeable”
5 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo – QA/QC User with Unlimited Access44
 Transaction MSC2N (Change Batch):
 All fields on Basic Data 2 View are shown as Changeable”
6 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo – QA/QC User with Unlimited Access44
 Transaction MSC2N (Change Batch):
 All Characteristics on Classification View are shown as “Changeable”
7 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo –non-QA/non-QC User with Restricted
Access
44
 Transaction MSC2N (Change Batch):
 All fields on Basic Data 1 View with no access are shown as “Display Only”
8 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo – non-QA/non-QC User with Restricted
Access
44
 Transaction MSC2N (Change Batch):
 All fields on Basic Data 2 View with no access are shown as “Display Only”
9 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Demo – non-QA/non-QC User with Restricted
Access
44
 Transaction MSC2N (Change Batch):
 Characteristics on Classification View with no access are shown as “Display Only”
 In example below, User has access to only change 2 characteristics
10 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Solution Merits55
 Material Batch Master Change Control Solution Merits:
 Controlled access to every Material Batch Master field and Characteristic
 Custom Authorizations and Roles pre-delivered with Solutionp
 Authorizations and Roles support Segregation of Duties and GxP
Compliance i.e.:
 Unlimited access for QA/QC Users Unlimited access for QA/QC Users
 Controlled access for non-QA/non-QC Users
 Overcomes limitation with core SAP functionality which lacks Authorization
Obj t t Fi ld d Ch t i ti l lObjects at a Field and Characteristic level
 Solution built without any SAP source code modification and is upgrade
compatible
 Solution alleviates any risk of granting access to non-QA/non-QC Users to
Txn MSC2N
11 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Our Value Proposition66
 Reduced TCO, Highest First Pass Yield and Highest Quality from:
 Strong expertise in providing end-to-end Supply Chain, Order to Cash and
Distribution Solutions
 Strong Expertise implementing SAP, enriching Business processes and
alleviating GAPs in SAP, for Life Sciences, Consumer Products, Chemical and
High-Tech Industry segments
 Very experienced consulting resource base with 13+ years experience and
deep 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
with:
 Pre-configured Solutions
 demo-able SAP Functionality
 Demo-able IT Sapiens custom solutions
12
Demo able IT Sapiens custom solutions
 Framework to develop strawman solutions
 Our “Say-To Do” Ratio is 1:1June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential
Questions ?77
 For more information…kindly contact
Vijay Pisipaty
Director-ERP Solutions & Consulting
IT Sapiens, Inc.
e-mail: vijay.pisipaty@itsapiens.com
13 June 22th 2013 ©2013 IT Sapiens, Inc.
Proprietary and Confidential

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SAP Material Batch Master Change Control Solution

  • 1. Material Batch Master Change ControlMaterial Batch Master Change Control • Segregation of Duties • GxP Compliance• GxP Compliance Solution BriefSolution Brief
  • 2. Index Synopsis11 General Life Sciences Industry Requirements22 ’IT Sapiens’ Solution Features33 Solution Demo44 Solution Merits55 Our Value Proposition66 1 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential Questions ?77 Our Value Proposition66
  • 3. Synopsis11  SAP Standard Functionality:  SAP Standard Functionality around Material Batch Master:  Provides ability to maintain the Batch Status “Unrestricted” orProvides ability to maintain the Batch Status Unrestricted or “Restricted”  Provides ability to maintain Batch properties using Classification Class and CharacteristicsClass and Characteristics  Provides ability to maintain Batch Shelf Life Expiration Date, GR Date, etc.  SAP Standard Functionality around Material Batch Master:  DOES NOT Provide ability to control/restrict Batch Characteristics maintenance/change by characteristic  DOES NOT provide ability to control/restrict Batch Shelf Life Expiration Data and other fields maintenance/change at a field level  DOES NOT Provide ability to control/restrict Batch Master Data by 2 DOES NOT Provide ability to control/restrict Batch Master Data by View (e.g. Basic Data 1, Basic Data 2, etc). June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 4. Material Batch Master Change Control – Requirements22  Life Sciences Industry Requirements for Batch Master Change Control:  Need ability to provide access to non-QA and non-QC users to update/maintain Material Batch Master without risk of changing GxP relatedupdate/maintain Material Batch Master without risk of changing GxP related fields:  Need ability to control Batch Characteristics update by Characteristic  e g No access to update Batch Valuation code Characteristic e.g. No access to update Batch Valuation code Characteristic  e.g. No access to update Batch Status Characteristic  e.g. No access to update Batch User Status Characteristic  e.g. Access to update Tablet Weight Characteristic  e.g. Access to update DEA Schedule, etc.  Need ability to control access to Batch Master Basic Data 1 View at a field level  Need ability to control access to Batch Master Basic Data 2 View at a field level 3 field level (Contd…) June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 5. IT Sapiens’ Solution Features33  Solution Excerpts:  Custom Authorization and checks incorporated into core SAP Txns MSC1N, MSC2N without any source code modifications  Ability to control access to Material Batch Master at View level (e.g. Basic Data 1, Basic Data 2  Ability to control access to every field on Batch Master in Txn MSC2NAbility to control access to every field on Batch Master in Txn MSC2N  e.g. Fields with no access are changed to “Display Only” fields in Txn MSC2N  Ability to control access to every Characteristic in Batch Maser in Txn Ability to control access to every Characteristic in Batch Maser in Txn MSC2N  e.g. Characteristics with no access are changed to “Display Only” Characteristics in Txn MSC2N  Separate Authorization Roles for QA/QC and non-QA/non-QC users that supports Segregation of Duties and GxP compliance 4 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 6. Solution Demo – QA/QC User with Unlimited Access44  Transaction MSC2N (Change Batch):  All fields on Basic Data 1 View are shown as “Changeable” 5 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 7. Solution Demo – QA/QC User with Unlimited Access44  Transaction MSC2N (Change Batch):  All fields on Basic Data 2 View are shown as Changeable” 6 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 8. Solution Demo – QA/QC User with Unlimited Access44  Transaction MSC2N (Change Batch):  All Characteristics on Classification View are shown as “Changeable” 7 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 9. Solution Demo –non-QA/non-QC User with Restricted Access 44  Transaction MSC2N (Change Batch):  All fields on Basic Data 1 View with no access are shown as “Display Only” 8 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 10. Solution Demo – non-QA/non-QC User with Restricted Access 44  Transaction MSC2N (Change Batch):  All fields on Basic Data 2 View with no access are shown as “Display Only” 9 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 11. Solution Demo – non-QA/non-QC User with Restricted Access 44  Transaction MSC2N (Change Batch):  Characteristics on Classification View with no access are shown as “Display Only”  In example below, User has access to only change 2 characteristics 10 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 12. Solution Merits55  Material Batch Master Change Control Solution Merits:  Controlled access to every Material Batch Master field and Characteristic  Custom Authorizations and Roles pre-delivered with Solutionp  Authorizations and Roles support Segregation of Duties and GxP Compliance i.e.:  Unlimited access for QA/QC Users Unlimited access for QA/QC Users  Controlled access for non-QA/non-QC Users  Overcomes limitation with core SAP functionality which lacks Authorization Obj t t Fi ld d Ch t i ti l lObjects at a Field and Characteristic level  Solution built without any SAP source code modification and is upgrade compatible  Solution alleviates any risk of granting access to non-QA/non-QC Users to Txn MSC2N 11 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 13. Our Value Proposition66  Reduced TCO, Highest First Pass Yield and Highest Quality from:  Strong expertise in providing end-to-end Supply Chain, Order to Cash and Distribution Solutions  Strong Expertise implementing SAP, enriching Business processes and alleviating GAPs in SAP, for Life Sciences, Consumer Products, Chemical and High-Tech Industry segments  Very experienced consulting resource base with 13+ years experience and deep 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 with:  Pre-configured Solutions  demo-able SAP Functionality  Demo-able IT Sapiens custom solutions 12 Demo able IT Sapiens custom solutions  Framework to develop strawman solutions  Our “Say-To Do” Ratio is 1:1June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential
  • 14. Questions ?77  For more information…kindly contact Vijay Pisipaty Director-ERP Solutions & Consulting IT Sapiens, Inc. e-mail: vijay.pisipaty@itsapiens.com 13 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential