Risk & evidence
Audit trails: test correction, identity and context
Test whether an MES reviewer can explain a correction, identity, time and record context. Assess retrieval, export and privileged change procedures.
A practical meeting agenda for the people who will authorize the pilot.
0 / 10 completed
Use this checklist in a meeting with production, quality, maintenance, IT, OT and the project sponsor. Check an item only when the team can point to a document, test result or observed demonstration. Progress is saved in this browser only. Do not enter proprietary production records or personal information. The reset button clears the saved selections.
In an illustrative pilot, the team can dispatch an order and capture production but has not tested a duplicate completion message. Leave the data item unchecked, assign the integration owner and schedule a replay test. A high completion count does not compensate for an unresolved critical risk.
This is an editorial planning checklist, not a safety assessment, regulatory audit, certification or assurance that a pilot should proceed. Add requirements specific to your products and quality system. The sponsor should explicitly record blocking issues and who may authorize their closure. A complete checklist still needs a review of the evidence and a decision by the people responsible for the plant.
Risk & evidence
Test whether an MES reviewer can explain a correction, identity, time and record context. Assess retrieval, export and privileged change procedures.
Risk & evidence
Establish electronic-record scope and intended use before assessing MES Part 11 controls. Prepare questions for qualified quality and regulatory staff.
Risk & evidence
Test MES genealogy backward and forward with splits, merges, substitutions and corrections. Reconcile meaningful relationships and capture limits.
Plan & prove
Assign ownership for MES items, units, routings and revisions. Test meaning, effective versions and relationships before migration and cutover.
Plan & prove
Design an MES pilot around a decision, representative workflow and acceptance evidence. Test exceptions and close with an accountable rollout gate.
Plan & prove
Translate production problems into observable MES behavior, with owners, priorities and acceptance tests that expose ambiguity before procurement.