Audit trail review
Audit trail review is a defined SOP-driven activity in which someone examines a system’s audit trail for entries needing explanation — changes, deletions, out-of-sequence entries, activity by unexpected users — on a frequency set by regulation or by risk assessment. It is a reviewable, structured activity, not a browsing session.
How often: where a CGMP regulation specifies a review frequency for the data itself, FDA’s 2018 data integrity guidance says to apply that same frequency to the audit trail review; otherwise set it by process knowledge and risk assessment. A draft revision of Annex 11 (consulted July–October 2025, not adopted) proposes materially stronger expectations, including review by personnel independent of the activity — it is a draft, not a requirement, and no adoption date has been published.
What makes a system easy or hard to review is the ability to narrow: ask a question — everything that happened to this piece of equipment, everything this user did, everything changed in this window — and get an answer over the whole record, not just whatever happened to load.
What MYREX supports today: free-text search and filtering by action, entity type and date range. It does not filter by asset or location, and its filtering operates over the entries loaded in the browser rather than over the whole record — adequate for investigation, not for an activity your SOP calls audit trail review, and we would rather say so than have a customer perform a regulated review in a screen we know behaves that way. The complete record is available through an export that carries the hash, the previous hash and the hash version on every row, so it can be re-verified outside our software.
Sources and notes
FDA, Data Integrity and Compliance With Drug CGMP: Questions and Answers, December 2018 · EudraLex Volume 4, Annex 11, clauses 9 and 12.4, January 2011 (in force) · European Commission stakeholder consultation on a revised Annex 11 and new Annex 22, July–October 2025 (closed; not adopted).
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