QA & inspection
QA and inspection check that data and process are traceable: read and export the audit trail, verify the integrity of its chain and assemble the inspection packet. An inspector works read-only and for a limited period.
Your day: frequent tasks
Section titled “Your day: frequent tasks”- Assemble the inspection packetAssemble an evidence ZIP for an inspection in one action — audit trail with chain verification, anchors, access snapshot and design versions; always blinded and verifiable offline.
- Export the audit trailExport the audit trail of a study, site or subject as a file — XLSX to read, PDF to print or CSV for independent verification — with the screen's current filters.
- Give an inspector accessGive an inspector or sponsor auditor view-only access for the inspection period — data, value history, audit trail and hash-chain verification, with no editing, export or unblinding.
- Verify the audit chain integrityRecompute the audit trail's hash chain and confirm that no record has been changed, deleted or back-dated into the middle.
Good to know
Section titled “Good to know”- Audit trail — what is recorded and why the trail cannot be rewritten.
- Electronic signatures and Part 11 — how a signature works.
- Documents and certified copies — which documents the system assembles.