Which components are included in system validation for electronic GLP data?

• A. IQ, OQ, and PQ.
• B. Only data backup.
• C. Software licensing.
• D. System validation, data integrity verification, and periodic revalidation.

Answer: (D)

In GLP, electronic data systems must be treated as validated across their whole lifecycle. The best approach includes not only proving the system works during initial testing but also ensuring data remain accurate, complete, and traceable as they move through the system, and confirming that the validated state is maintained over time. This means three components: formal system validation, data integrity verification (checking accuracy, completeness, and traceability with appropriate controls like audit trails and access controls), and periodic revalidation to account for changes or time-related drift. Together, these elements maintain trustworthiness of the data from capture to reporting.

The other options fall short because they address only pieces of the picture. IQ, OQ, and PQ are the steps of initial validation but don’t by themselves guarantee ongoing data integrity or revalidation. Data backup covers protecting data availability but not the broader assurance of data integrity or ongoing validation. Software licensing is about permissions and procurement, not about validating the system’s ability to produce reliable, compliant GLP data.