Are you reviewing your audit trails?

The Code of Federal Regulations (21 CFR 211.194 Laboratory Records), states that laboratory records must be reviewed for accuracy, completeness, and compliance with established standards. One of the things that needs to be reviewed when reviewing laboratory data is the audit trails. Guidance for Industry Data Integrity and Compliance with Drug cGMP Questions and Answers states: “Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record. For example, all production and control records, which includes audit trails, must be reviewed, and approved by the quality unit”.  Audit trails should be reviewed with enough frequency to ensure that cGMP requirements are met, appropriate controls are implemented, and the reliability of the review is proven.

A company recently received the following observation:

….. Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Specifically, your SOP # …, “Laboratory Data Review”, states ‘Quality Assurance will provide oversight to the data review process, including the associated review of audit trails, to ensure the audit trails are being incorporated as part of routine data review.’  However, as of the close of the current inspection, your Quality Assurance had not conducted any formal audit trail reviews as required by your SOP.

For more information on implementing controls for electronic systems, refer to the FDA Guidance Document, Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application August 2003.

To view more observations pertaining to data integrity, refer to the following GMP Trends® Issues: 1109, 1104, 1100, and 1090,

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