Review on Computer System Validation in Regulated Pharma Environments: Classification, Lifecycle Models, Compliance Challenges, and FDA Expectations

Computer System Validation (CSV) is a fundamental requirement in the pharmaceutical industry to ensure the reliability, data integrity, and security of computerized systems operating in GxP regulated environments. This review underscores the critical role of CSV in safeguarding patient safety and achieving compliance with international regulatory standards, including FDA 21 CFR Part 11 and ISPE GAMP 5 guidelines. Structured validation methodologies particularly risk-based approaches such as the V-Model and Agile are explored for their effectiveness in maintaining the validated state of systems throughout their lifecycle. The article examines common CSV challenges, including poorly defined user requirements, weak change control, insufficient testing, and inadequate traceability, and discusses their implications on regulatory compliance. Through the analysis of actual FDA inspection findings, the review highlights frequent deficiencies such as incomplete validation documentation, data integrity breaches, and audit trail failures. These issues are mapped to underlying CSV gaps, emphasizing the importance of proactive planning, comprehensive documentation, and routine review practices. The review concludes with practical preventive measures that pharmaceutical companies can adopt to reduce regulatory risk, enhance system robustness, and foster a culture of compliance and quality in computerized system environments.