SAP Material Batch Master Change Control Solution

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 Requirements 22

’IT Sapiens’ Solution Features33

Solution Demo44

Solution Merits55

Our Value Proposition66

1 June 22th 2013 ©2013 IT Sapiens, Inc. Proprietary and Confidential

Questions ?77


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


Solution Demo – QA/QC User with Unlimited Access44

Transaction MSC2N (Change Batch): All fields on Basic Data 1 View are shown as “Changeable”



Transaction MSC2N (Change Batch): All fields on Basic Data 2 View are shown as Changeable”



Transaction MSC2N (Change Batch): All Characteristics on Classification View are shown as “Changeable”


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”


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”


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


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 Solution p 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



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 PisipatyDirector-ERP Solutions & ConsultingIT Sapiens, Inc.e-mail: [email protected]


Technology

SAP Material Batch Master Change Control Solution