Computerized System Validation
Consulting provided to assess existing validation status, respond to CSV findings from audits and inspections, or establish validation approach for new technologies supporting clinical trial conduct, analysis, or design.
Computerized System Validation (CSV) is a foundational component necessary to achieving compliance with 21 CFR Part 11 Electronic Records; Electronic Signatures regulation. The requirement for Risk-based CSV is now fully incorporated into ICH E6(R2).
Both vendor supplied systems acquired commercially off the shelf (COTS) as well as systems developed in-house require formal documented validation to demonstrate that the system implemented is fit for its purpose, is accurate and consistent in its performance, and is able to detect altered and invalid records.