Computer System Validation (CSV)
From WikiBioPharm
“The formal assessment and reporting of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, re-qualification, maintenance and retirement. This should enable both the regulated user, and competent authority, to have a high level of confidence in the integrity of both the processes executed within the controlling computer system(s) and in those processes controlled by and/or linked to the computer system(s), within the prescribed operating environment(s).”
This was taken from the Pharmaceutical Inspection Co-operation Scheme, “Good Practices for Computerized Systems in GxP Regulated Environments,” July 2004.
21 CFR Part 11
21 CFR Part 11 has become a fundumental influence on computer system validation. Entitled Electronic Records; Electronic Signatures, the regulation results in remedation often using a Part 11 Compliance Checklist that mirrors the regulation.
