Computer system validation (CSV)
Risk-based validation that proves your GxP systems are fit for purpose, compliant and inspection-ready — from planning to retirement.
Trustworthy systems behind trustworthy data
Clinical and pharmaceutical decisions depend on data captured, processed and stored in computerised systems.
Computer System Validation provides documented evidence that each system consistently does what it is intended to do — protecting patient safety, product quality and data integrity. Our approach follows GAMP 5 and the FDA's Computer Software Assurance (CSA) thinking: focus effort where risk is highest.
A structured, risk-based approach
Plan
Validation master plan, system inventory and GxP impact assessment.
Specify
User requirements, functional specs and risk assessment.
Verify
IQ, OQ and PQ protocols executed with traceability.
Report & Maintain
Summary report, change control and periodic review.
Validation deliverables
- Validation Master Plan (VMP)
- User Requirement Specification (URS)
- Risk & GxP impact assessments
- IQ / OQ / PQ protocols and reports
- Requirements traceability matrix
- Validation summary report
Systems we validate
- EDC and ePRO platforms
- CTMS and eTMF systems
- Safety / pharmacovigilance databases
- LIMS and laboratory instruments
- IRT / RTSM systems
- GxP spreadsheets and SaaS tools
Compliance services
- 21 CFR Part 11 & Annex 11 gap assessments
- Data integrity (ALCOA+) audits
- Supplier and vendor assessments
- Audit trail and access reviews
- Periodic review and revalidation
- System retirement and data migration
Common validation questions
Any computerised system that creates, modifies, stores or reports GxP data — for example EDC, CTMS, safety databases, LIMS and even business-critical spreadsheets — should be validated in proportion to its risk.
Computer Software Assurance is the FDA's risk-based evolution of CSV. It emphasises critical thinking and testing where risk is highest, reducing unnecessary documentation while keeping systems compliant.
Yes. We combine supplier assessments, configuration verification and risk-based testing to validate SaaS tools under GAMP 5 category guidance.
We prepare validation packages, traceability and data integrity evidence so your teams can confidently answer regulator and sponsor auditor questions.
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