SAP S/4HANA GxP Validation | Migration  21 CFR Part 11 | ADN

Compliant with GAMP 5 Second Edition

21 CFR Part 11
GMP Annex 11

​Migration to SAP S/4HANA is one of the most critical projects for the GxP compliance of pharmaceutical manufacturers and medical device makers. ADN qualifies the regulatory impact of your migration from the diagnostic phase onward, then supports the validation of critical SAP modules through to the final report.
 

Our approach to SAP validation
 

We begin with a pre-migration CSV assessment that defines the real GxP scope and sets the validation strategy. The effort is then scaled to the risk of each module, in line with the risk-based approach of GAMP 5 Second Edition and the Computer Software Assurance (CSA) published by the FDA in 2022.

SAP modules covered
 

• QM (Quality Management): quality control, inspection plans, batch management

• MM (Materials Management): receiving, inventory, materials traceability

• PP (Production Planning): production orders, bills of materials

• SD (Sales & Distribution): shipping, traceability for batch recall

• PM (Plant Maintenance): maintenance of GxP equipment

• WM (Warehouse Management): warehouse management
   

Our validation deliverables
 

• Pre-migration CSV assessment: regulatory impact, GxP scope, strategy

• GAMP 5 categorization and per-module impact analysis

• Specifications and functional risk analysis

• IQ/OQ/PQ protocols and scripts

• 21 CFR Part 11 compliance testing: audit trail, access control, electronic signatures

• Requirements-tests-results traceability matrix

• Validation report
   

Regulatory compliance
 

Our deliverables meet 21 CFR Part 11 (FDA) and Annex 11 of the European GMP for electronic records and signatures. We also work on both Brownfield and Greenfield implementations and integrate validation into your SAP DevOps practices.
 

Frequently asked questions
 

How do you validate a SAP S/4HANA migration in a pharmaceutical environment?
 

Validating an S/4HANA migration starts with a regulatory impact assessment that identifies the affected GxP processes, then applies a per-module GAMP 5 categorization before rolling out mitigation measures targeted at the critical functions previously identified through a risk analysis.
 

Which SAP modules are affected by GxP validation?
 

The most frequently affected modules are QM, MM and PP, as they carry quality control, batch traceability and production. SD, WM and PM are affected depending on the system scope.
 

What is CSA and does it change SAP validation?
 

Computer Software Assurance is the FDA's 2022 approach that refocuses testing effort on patient risk and product quality while reducing low-value documentation. It applies fully to SAP projects. 

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Can I relieve my users of tasks seen as time-consuming?

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Yes, we offer solutions that let AI agents run tests in place of your key users, and help overcome writer's block when drafting specifications.