An Accelerated SAP Implementation Approach in Validation GMP Environments

2. What needs to be validated?
Software Hardware Equipment
1 2 4
Operating
Procedures and
Documentation
5
Controlling System Controlled Process
(Computer System) 6
3
Total System
(Computerized System) ... and
7 all the links
between the boxes
Operational Environment
8

3. ASAP Roadmap
Project Prep Blueprinting Realization Final Prep. Go-Live
Unit System
Concept Requirements Design Build Installation Maintenance
Test Test
Industry-recognized SDLC

4. VMP CONCEPT & OPERATION &
REQUIREMENTS MAINTENANCE
Audit
Report PROD ONGOING
APPLICATION SELECTION
LIVE MONITORING &
USER REQUIREMENTS
SYSTEM MEETS ORIGINAL SELECTION CHANGE CONTROL
ASAP CRITERIA AND USER REQUIREMENTS SOP
SOP
Scenario Transports
FUNCTIONAL REQUIREMENTS CATT
Process SPECIFICATION QA SYSTEM
BUSINESS PROCESS MODEL ACCEPTANCE
SOPS SYSTEM PERFORMS INTENDED TESTING
INTEGRATED FUNCTIONS
D BPP T
R/3
1 BPP per Process Test
Best E E Workbench
Practices S
BPP
DEV S
SYSTEM DESIGN SPECIFICATION
I PROGRAM SPECIFICATION PROCESSES & PROGRAMS
UNIT TESTING
T R/3 Cross
G PERFORM INTENDED
BAPI I
System
Config FUNCTIONS Viewer
N Docs N
ABAP
PROGRAM SPECIFICATION DEV G
PROGRAMMING STANDARDS
STRUCTURAL BC Sets
CODE CODE REVIEW
SOURCE CODE
COMPLIES
Tech. TO STANDARDS
Specs
BPML R/3 IMG DEV
Business Process Master List
CONFIGURE / CODE
BC Sets
DEVELOPMENT

5. Project Project Management
Start-up
Plan & Control & Control & Control & Control &
Organise Manage Manage Manage Manage Close
Project
Life Cycle Phases
Business
Define Blueprint Realisation
Testing
Final Prep Go-Live &
Support
Cross-Phase Activities
Data Migration
Authorisations
Define
SOP‘s
Training
Validation
Impacts “Validation” Deliverables
Plan Risk ER/ES Validation
Assessment Assessment Report
Validation Reviews & Support

6. Project/Validation Deliverable Matrix
Phase Design Qualification Implementation Operational Qualification Performance
Qualification Solution Integration Data Migration Qualification
Project Master Validation Plan
Preparation User Tech specs Business Application Data Retention
Requirements Process Scope Landscape & Plan
Sys Landscape
Specification Integration
Data Migration
(URS) Backup & Recovery Scope
Plan
Risk Assessment Configuration Transfer Plan
Project Schedule DEV System Build
Blueprint SAP Best Practice QAS Build Solution Design Integration Data Templates Training
Base & Bldg Specification Specifications Needs
Manual Configuration Log Data Acquisition &
blocks (Blueprint) Assessment
Validation
Best Practice
Procedures
Realisation PRD Build Test Plan Data Training Plan
Transformation &
Manual Configuration Test Cases / Scenarios / Data Training
Validation
Material
QAS / PRD Configuration Unit / System / Integration
Validation Testing
User Acceptance Testing

7. Project/Validation Deliverable Matrix
Phase Design Implementation Operational Qualification Performance
Qualification Qualification Solution Integration Data Migration Qualification
Final Cutover Plan Cutover Static Data Load & Training delivery
Preparation Schedule Validation
Training
assessment
Go-Live Check
Performance Test
Go-Live Cutover execution Transitional Data System
Load & Acceptance
Validation
Support Post Implementation Project Transition
Support System Maint.
Issues Management

8. Requirements
SOP‘s /
Business Scope
Transaction
Scenarios List
Aids
Business Risk
Test
Process Assess-
Scripts
Procedures ment
Data
Functional
Conversion
Spec
Documents
Technical
Spec

9. The Requirements Document represents a
requirement of the system
Keep Requirements at a higher level, rather than
detail level.
Singular requirement statements (non-SAPified)
There are 3 categories of Requirements:
Functional
Performance
Security
Requirements are classifed either GMP or non-GMP
Electronic Records / Electronic Signatures (ER/ES)
relevance is indicated at the requirement level

10. The Business Scenario provides a high-level
overview of the end-to-end business processes
Requirements Documents are linked into the
Business Scenarios
◦ There is not necessarily a 1:1 relationship between
Business Scenarios and Requirements Documents
◦ There may be Business Scenarios required from SAP,
which cannot be linked to a specific Requirement
This is the first document level linked into SAP

11. Builds on the Business Scenario Description
Provides a detailed description of the individual
steps executed during scenario execution
Detailed description of process in
“business/functional language”
Basis for Configuration of the System
Highlights variations to the standard execution of
the Business Process
Will provide cross-references to SAP Transactions
and or developments involved
Maps Job Functions into the Process execution
Enables Validation of initial Project Enterprise
Requirements

12. Builds on Business Process Document
Provides the detailed specification for
developments required
Is the process of translating business requirements
into functional and technical requirements
Require close cooperation between business and
functional/technical people
Occurs during Realisation
Technical Specification provides Object level detail
of technical developments
Technical Specification is drafted before
Development Starts, and completed and approved
after formal unit testing.

13. Data Map - specify data source and target
FS - specify tools for conversion
DVP - specify the verification process
DVRD - record result of data verification

14. Approval of Document Version 1.0 is baselining the
document
Baselining is the start of formal change management
Baselining should happen as late as possible in a phase
(or as late as required in a phase)
Document review and approval meetings (presentations)
might be conducted

15. All Documents need to be printed and signed at the
appropriate time
A central document management function /
resource should control the documents once
released / signed
Formal change control needs to be applied once a
document is baselined
Ensure document history is updated at each change
Version number increases for each change cycle
◦ Full step for each version change (ie 1.0 -> 2.0)
◦ Point-increment when released for approval (ie 1.0 -> 1.1)

16. All specification documentation is complete and signed off
e.g.:
◦ Requirements Documents
◦ Business Scenario Documents
◦ Scope List / BPML (Business Process Master List)
◦ Business Process Documents
◦ Organisational Structure
◦ Functional Specifications
◦ Test Strategy
◦ Test Scripts
◦ Data Conversion Strategy
◦ Authorisation Concept
◦ Project Change Control Plan & Documentation Standard
All processes to be applied in the Realisation phase are
described, approved and trained.

17. Phase Compl.
Criteria
Blue Print
satisfied
N/A on Formal
Test Cycle 1
Generic Unit Test Functional/Dev DevelopmentTeam
Scripts
Defect
IUT execution
Informal / Formal Unit Test
Unit Testing Management
Typically Executed in DEV Environment
Functional
Specifications
Approved
Approved Unit Informal Defect
Formal Unit Project Team/SME
Test Scripts Management
Testing Process IUT execution
Transports Released
Formal
QA System
Entry Gate
Review Informal
Test Cycle 2
N/A on Defect
Cutover & Management
Informal Integration Test
Manual Test Data Typically Executed in QA Environment
Informal Integration
Test Plan Informal Integration Informal Defect Project Team/SME
Informal Integration
(Sequenced Test Test Results Management
Testing IIT execution
Scripts) Process
Defect Status
Tracking/Report

18. Formal
Acceptance System
Test Entry Refresh
Gate
Review
Formal
Formal Defect Test Cycle 3
Management
Cutover Dry-Run Process Formal User Acceptance Test
UpdatedFormal Busniess/SME
IntegrationTest Plan Formal User Formal User Formal UAT execution
(Sequenced Test Acceptance Acceptance Defect Management with Project
Scripts) Testing Test Results Process
Team
Support
Stability Test Formal
Stability
Results Defect Management
Testing Process Test Report
Performance Formal
Performance
Test Results Defect Management
Testing Process

19. ER/ES GmP Impact Assessment – SAP Record Map
Vendor Material
Quality Doc. Info Customer
Master Purchase
Master Master
Info. Record
Info.
Purchase Inspection Bill of Inspection
Info. Chrcteristic Material Chrcteristic
Cert. Assignment
Quality Inspect’n Master Inspect’n Certificate Sales Info
Info. Plan Recipe Plan Profile
Reference
Records
Sales
Unit/Operation
Batch Sub-contract Batch Batch
Master Master Determ’n Order Records
Manufacture
Process Order
Purchase Goods Goods PI Goods Batch Goods
Order Receipt Releas Issue Sheet Receipt Releas Delivery Issue
e e
Inspection Lot Inspection Lot
Results e-Batch Quality P. Mtce Results Scrap
Record Record Notificat’n Notificat’n Record
Material Material Material Cert. of Material Material
Doc. Doc. Doc. Analysis Doc. Doc.
Material Where-
Requirem’t used
Key
Direct Indirect No
Material Decisio
Impact Impact Impact
Flow n

20. Permanent The information can’t be changed, erased or washed off.
Legible The information can be easily read.
Accurate Calculations are correct and other information is recorded with care.
Prompt Information is recorded in a timely way. Actions are documented
immediately after they are performed, never before.
Clear Everyone who reads the document has the same understanding of
what it means.
Consistent All information, such as dates, times, abbreviations, etc. should be
standardized so there is no room for confusion.
Complete All required information is included.
Direct Information is recorded immediately onto the proper form (I.e. test
scripts).
Truthful All information included in the document is, to the writer’s knowledge
and ability, what really happened.
GMP Good Documentation