How should electronic data be validated before use in GLP?

• A. System validation (IQ/OQ/PQ), data integrity verification, and periodic revalidation.
• B. No validation required.
• C. Validation only after data submission.
• D. Validation by external auditors only.

Answer: (A)

Electronic data in GLP must be trustworthy, accurate, and protected from tampering. To achieve this, the system used for data handling should be validated before it is used, covering installation, operation, and performance to confirm it is set up correctly, works as intended, and can produce reliable results. In addition, verifying data integrity—ensuring data are complete, accurate, traceable, and securely stored with proper audit trails and access controls—along with periodic revalidation after changes or over time, keeps the data trustworthy throughout its lifecycle.

This comprehensive approach is why validation that includes IQ, OQ, PQ, data integrity verification, and periodic revalidation is the best answer. Other options fail to ensure pre-use validation, ongoing integrity checks, or both, which GLP requires to protect the quality and reliability of electronic data.