Free Guide
SAP S/4HANA Validation Guide for Life Sciences
This guide is for CSV and validation leads running a greenfield SAP S/4HANA rollout at a pharma or biotech company.
It shows how to meet FDA, EMA and global compliance expectations while reaching go-live faster, using Agile SAFe and Computer Software Assurance (CSA).
What’s inside
- Module-by-module validation guidance for SAP GxP modules such as QM, PP-PI and ATTP
- Alignment with FDA 21 CFR Part 11 and EU Annex 11
- A validation lifecycle mapped to the Scaled Agile Framework (SAFe)
- Risk-based testing using CSA
- Paperless validation examples in Jira and Xray
- Templates: URS, Functional Specification, Trace Matrix and Test Protocols