FDA Data Integrity CGMP Guidance
Widely used framework for ensuring data integrity through principles such as attributable, legible, contemporaneous, original, accurate, complete, and available records.
What You Can Expect
Practical insights you can apply right away.
ALCOA Is the Data Integrity Standard
FDA defines data integrity as the completeness, consistency, and accuracy of data, using the ALCOA framework: data must be Attributable, Legible, Contemporaneously recorded, Original or a true copy, and Accurate. These principles apply throughout the entire data lifecycle from creation through disposition.
Audit Trails Are Non-Negotiable
Electronic systems must maintain secure, time-stamped audit trails that capture all creation, modification, and deletion of records. Audit trails must be reviewed with the same frequency as the underlying data and cannot be disabled, altered, or selectively retained to obscure prior results.
System Design Prevents Integrity Failures
FDA expects computer systems to be validated for their intended use, restrict access to authorised individuals, prevent shared login credentials, and automatically save data at the time of performance. Technical controls should make it difficult to manipulate data without detection, reducing reliance on procedural safeguards alone.