GLP Computer System Validation Audit Checklist

The checklist covers areas such as system requirements specification, risk assessment, validation planning, installation qualification, operational qualification, performance qualification, user acceptance testing, change control procedures, and system retirement processes.

Full validation audits should be conducted during initial system implementation and after major upgrades. Periodic re-validation or audit checks should be performed annually or when significant changes occur in the system or its use.

The audit should involve a cross-functional team including IT specialists, quality assurance personnel, validation experts, system owners, and end-users to ensure a comprehensive assessment of the system's compliance and functionality.

By ensuring computer systems are properly validated, this checklist helps maintain the accuracy, reliability, and traceability of electronic data generated and managed in GLP studies, supporting overall data integrity throughout the research lifecycle.

Yes, while maintaining core validation principles, the checklist can be adapted to various types of computer systems used in GLP environments, such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), or analytical instrument software.