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SAP PQ TestingAstellas Europe

V1.0May 22, 2014

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Introduction SAP PQ Testing

Harry van der Pol

SAP Validation Manager Astellas Pharma Europe

Simon de Groot

SAPOPS Test Manager Astellas Pharma Europe (external)

Purpose presentation:

Executing of PQ tests for the SAP application (both projects and small changes), supported by a software application

Demonstrate how the software supports the validation of the SAP application

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**Validation**

Starting Point: SAP Validated State is achieved

Establishing documented evidence is available, which provides a high degree of assurance that a specific process will consistently produce a product meeting it’s predetermined specifications and quality attributes…

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Qualification Challenges at Astellas Europe SAP PQ Testing

1. Complex process flows between various organizational entities that need to be verified (End-to-End processes)

2. Many organizational entities use the same SAP system

3. How do you manage the User Requirements and relations

4. PQ scripts, requirements

5. Manage PQ Execution (e.g. (Progress-) Reporting, Incidents Management)

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Challenge: Complex process flows

Manage PQ Scripts:

• Different processes

• Different Testers

• Sequence

dependency (E2E)

• Distribution testers

• Status PQ Scripts:

• Approval?

• Progress?

• Incidents?

• Completed?

PQ Script dependency

# Activity SOP SAP-Tran Org. U Tester

10 Create PO P.2.1 ZME58 PT01 Mrs A

20 Confirm PO Extern Vendor Mrs Y

30 Ship Goods /Send Invoice

Extern Vendor Mr Z

40 Post Goods Receipt W.1.1 MIGO_GR PT01 Mrs A

50 Test and Release Batch

Q.2.1 QA11 PT01 Mr B

60 Post Vendor’s invoice

A.1.1.1 MIRO PT01 Mr C

70 Pay Vendor’s invoice

A.1.1.2 F110 PT01 Mrs D

Simple exampleof test complexity

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Solution 1: Complex process flows

• Drawing of Flows

with different entities

with interfaced 3d parties (vendors/distributors/Systems (e.g. LIMS)), etc

ca 90 variants

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Example: Complex process flows

Chain of activitiesIncludingOrg entity

Flows: Based on SOP’s

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Example SOP SAP Activity

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Challenge 2 Many Org. Entities share 1 SAP SAP PQ Testing

• Manage PQ Scripts:

One SAP Landscape

Several SAP systems

(ECC,HR,SCM,BW, etc)

used by all entities;

• Multi-lingual, Time-zones

• Distribution testers

• Status

• Approval?

• Progress?

• Incidents?

• Completed?

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Challenge 2 Many Org. Entities share 1 SAP SAP PQ Testing

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Solution 2: Complex process flows

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Solution 2 Many Org. Entities share 1 SAP SAP PQ Testing

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Challenge 3: Manage User Requirements SAP PQ Testing

1. One SAP landscape, different systems , different companies, (almost the) same requirements ?

2. Projects compiling project driven URS?

3. BAU (Changes), how do we know which URS is affected?

4. Hard to determine when a URS is tested?

5. Hard to determine in which protocol the URS is tested?

6. How do we know which URS is critical (GXP/JSOX)?

7. Manage Unique Coding for the (different) SAP systems?

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Solution 3: Master URS SAP PQ Testing

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Solution 3: SAP Master URS Reporting SAP PQ Testing

• No more re-invent the wheel...

• Compare between entities

• Trace-ability Matrix

• Coverage verification (all

URS covered?, test status)

• When tested for the last time?

• Risk Classification (Test Policy)

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Challenge 4: PQ scripts, requirements SAP PQ Testing

1. PQ Script should be:

• Read-only

• Easy to distribute to the testers

• Specify Relevant Test Data, Test Platform, Purpose, Who, Test Date, dependencies

• Easy to re-use/slightly adapt (automatically…)

• Link to referenced SOP and User Requirements

• Sign-off for Design Approval and for Test Execution Approval

limiting the number of “signatures”

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Solution 4: PQ scripts SAP PQ Testing

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Challenge 5: Manage PQ Execution (Progress)-ReportingSAP PQ Testing

1. Preparation, Review, Approval, …performers…URS coverage…

2. To manage approximately 10 projects per year, with about 180 scripts and 20 Testers per project

3. During PQ Testing on a daily basis report about Test Status, Incidents, etc

4. PQ tests overview and status by date, tester, E2E, etc , etc

5. Notify next tester in the chain of E2E

6. Trace-ability Matrix

7. Incident status, manage fixes that need a transport, organize re-test

8. PQ Summary Report

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Solution 5: Manage PQ Execution SAP PQ Testing

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Solution 5 Manage PQ Execution SAP PQ Testing

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Solution 5 Manage PQ Execution SAP PQ Testing

• Daily progress by:

• Over-all

• Tester

• Function etc

• Incident Management

• Trace-ability Matrix URS-PQ

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Test Solutions at Astellas Europe for SAP PQ Testing

To manage:

1. Complex process flows between various organizational entities (End-to-End processes)

2. Many organizational entities use the same SAP Landscape

3. The User Requirements and relations

4. PQ scripts

5. PQ Execution (e.g. (Progress-) Reporting), Incident Management)

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Thank You !