Testing & Validation
Testing & Validation
Risk-based testing and validation for regulated QC—CSA and CSV approaches aligned to Part 11, Annex 11, GxP, and GAMP 5, starting early in the project—not only at UAT.
We treat testing and validation as a way to improve integration quality from the outset— not only as a final gate before go-live. Engineers engage before the first script is written and continue through each phase of the software lifecycle.
Approaches that fit your QMS
- Computer Software Assurance (CSA) — risk-based focus on functions that affect patient safety, product quality, and data integrity
- Computer System Validation (CSV) — when your procedures require traditional system-focused validation
- Alignment to 21 CFR Part 11, EU Annex 11, GxP, and GAMP 5 principles
Automated testing
Automation reduces manual effort for regression, upgrade, and sprint testing while keeping coverage where risk is highest. Deliverables include:
- Regression packs for releases and hotfixes
- Faster acceptance cycles for configuration changes
- Traceable evidence packages for QA and IT
Sample engagement outline
- Scope critical workflows (sample → result → review → release)
- Risk assessment and test strategy (CSA vs CSV mix)
- Scripted / automated execution with defect triage
- Evidence pack and traceability to requirements
- Handoff into hypercare and Flex for ongoing change control
Related
Pair with Implementation so validation is not a last-minute scramble, and with Compliance product capabilities for Part 11 and ALCOA+ in the platform itself.