Computer System Validation (CSV) is a regulatory requirement according to regulations like 21CFR Part 11, ICH E6(R2) guielines. It is a critical process in the pharmaceutical and healthcare industry that ensures the integrity, reliability, and compliance of computerized systems used in various aspects of pharmaceutical operations, including manufacturing, quality control, research, clinical trials, and regulatory reporting.

GSK Calibrations offers software validation and CSV expertise to help you company comply with the latest regulations and Make it easy for you with the best compliance practices in the validation of IT systems supporting a multitude of companies in:

 User Requirements

 Validation Plan

 Risk Assessment

 Technical documents (Functional specification/Design specification)

 Traceability Matrix

 Installation Qualification(IQ)

 Operational Qualification(OQ)

 Performance Qualification(PQ)

 Final Validation report.