A comprehensive checklist for auditing pharmaceutical computerized system validation processes to ensure compliance with regulatory standards, maintain data integrity, and support reliable electronic record-keeping in pharmaceutical operations.
Pharmaceutical Computerized System Validation Audit Checklist
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About This Checklist
The Pharmaceutical Computerized System Validation Audit Checklist is a critical tool for ensuring the reliability, integrity, and compliance of computerized systems used in pharmaceutical operations. This comprehensive checklist addresses key aspects of computer system validation, from requirements specification to system retirement, helping to maintain data integrity and regulatory compliance. By implementing this checklist, pharmaceutical companies can enhance their computerized system validation practices, meet regulatory expectations, and ensure the consistent quality and reliability of their electronic records and data management processes.
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Ensures compliance with 21 CFR Part 11 and EU GMP Annex 11 for computerized systems
Improves data integrity and reliability across pharmaceutical operations
Enhances traceability and auditability of computerized system lifecycles
Reduces the risk of data-related compliance issues during regulatory inspections
Supports efficient and consistent validation practices across different systems
