CSV/GxP
Pharma
Computer system validation, traceability, evidence and change control for GxP environments.
Context
Teams operating critical systems, ERPs, Veeva, SAP or solutions subject to GAMP5, audits and regulated procedures.
How we help
- We define CSV/GxP strategies based on criticality, intended use and real risk.
- We connect requirements, risks, tests, deviations and evidence.
- We prepare sustainable validation models for changes and releases.
Use cases
- Validation of new implementations or upgrades.
- Automation of test evidence and reporting.
- Preparation of review and audit evidence packs.