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Prepare a GxP audit-trail review.

Organise audit-trail events around defined review questions, source versions and exceptions needing human assessment.

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Illustration of a seal beside an open evidence folio containing SOP, training and execution records.

You: Review the sample-identity correction in AT-309. Is the explanation supported?

neil

The record changed from S-91 at 10:00 to S-19 at 10:06, with a transposition reason. The source label image is absent. I can establish the six-minute change history, but not verify the corrected identity from that reason alone.

Correction retained; label is missing
Correction retained; label is missing. S-91, S-19, 10:00, 10:06. Example records.S-91→S-1910:0010:06

You: Does the recorded reason make the correction acceptable?

neil

It explains the asserted intent, not the underlying identity. I would inspect the original label or equivalent source evidence and trace any downstream records using either identifier. The review should preserve both values and assess the correction without assuming misconduct or correctness.

You: Write this up for review, with the sources and the follow-up work we need.

neil

Here is the draft. I have kept the supported finding separate from the open questions, and prepared the evidence requests for the responsible roles.

AT-309 identity-correction reviewReview draft · source evidence and assessment

AT-309 identity-correction review

The trail preserves both identities and the six-minute interval between the original entry and correction. The recorded transposition reason is relevant context, but the absent collection label is still needed to verify which identity is correct. Request that source and assess the affected downstream records. The existence of a correction alone is neither proof of misconduct nor proof that the corrected value is right.

Source evidence and search scope

AT-309-1 (Original value); AT-309-2 (Correction); SRC-309 (Supporting evidence)

AT-309-1 / Original value

Recorded evidence
Sample identity recorded as S-91 at 10:00

AT-309-2 / Correction

Recorded evidence
Changed to S-19 at 10:06; transposition reason recorded

SRC-309 / Supporting evidence

Recorded evidence
Collection label image not attached
Inputs needed for your own records
  • Audit-trail export with actor, timestamp and before/after values
  • Records and versions in the defined review scope
  • Review criteria, authorised workflows and supporting reasons

The authorised reviewer determines significance and signs the required review. An unusual event is not by itself evidence of misconduct.

Fictional source snapshots. No live query, assignment or approval.

Follow-up work and evidence requests2 proposed tasks · not assigned

Evidence to request

Provide the identity source
Sample record owner
Locate the original label or controlled source that supports S-19, preserving its link to the physical sample.
Assess the correction and downstream references
Audit-trail reviewer
Review who changed what, when and why; inspect affected results and references before recording the identity decision.
Example conversation · prepared replies

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What to bring for this job
  • Audit-trail export with actor, timestamp and before/after values
  • Records and versions in the defined review scope
  • Review criteria, authorised workflows and supporting reasons

Source access, permissions and permitted actions are agreed for your environment.

Source excerpt

AT-309-1

Original value

Recorded evidence
Sample identity recorded as S-91 at 10:00

Selected fictional record, not a live source-system view.

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