Computer System Validation (CSV)
GAMP5 and 21 CFR Part 11 compliant validation of computerized systems.
Our Computer System Validation services ensure your computerized systems perform reliably, consistently and in full regulatory compliance. Following a risk-based GAMP5 approach, we validate software and automated systems against FDA 21 CFR Part 11 and EU Annex 11, with complete documentation and data-integrity assurance throughout the lifecycle.
What We Offer
Validation Planning
Validation plans, user requirements and functional specifications.
Risk Assessment (GAMP5)
Risk-based categorisation and assessment of computerized systems.
IQ / OQ / PQ
Installation, operational and performance qualification of software.
21 CFR Part 11 / Annex 11
Electronic records and electronic signature compliance.
Data Integrity (ALCOA+)
Controls ensuring accurate, complete and traceable data.
Traceability & Reporting
Requirement traceability matrix and validation summary reports.
Key Benefits
Need Computer System Validation for your facility?
Tell us your requirement and our team will respond within 24 hours.