Qualification: IQ/OQ dry-run deviations fixed (EC-01, EC-06 to EC-10), complete execution report and "without an approved version" statement

2026.11.06-qualification-ecarts-essai-a-blanc · 2026-11-06

Delivered build : a41ab1ad531a3cebc66f295863100e3014e1be34

Changes

• EC-01: changing the inactivity timeout or the screensaver delay now writes a line to the audit trail, with the old and new values. If this record cannot be written, the change is cancelled.
• EC-06: a protocol deviation declared during a run (Execution notes, Protocol deviation) now enters the audit trail as soon as it is synchronised, with its text, category, step, author and declaration time. Synchronising again does not create a duplicate.
• EC-07: "Export CSV" on the Audit screen now delivers the whole log matching the screen filters, not only the rows on display. The export itself is recorded with the filters applied, and it is written page by page so it stays reliable on a very long trail.
• EC-08: the PDF report of a run now includes the measurements entered (stored value, without rounding) and the reagents consumed with their lot, including for very long consumption lists. A lot used after its expiry date is flagged, based on the state recorded at the time of use.
• EC-08: a "PDF report" button is now available on the page of a sealed run, without going through the Audit pack.
• EC-09: audit trail review now follows the lab's permission matrix. A role to which the lab grants audit trail verification or export can open the Audit screen and the Audit pack. The configuration history can also be read from the Audit screen.
• EC-10: the Audit pack now offers the "Full account export" command. It is shown only to people allowed to export the account and asks for a fresh proof of identity before sending.
• The report of a run now states which protocol version was followed and prints the approval of that version (version, date, author). A run performed without an approved version carries the statement "Run on the working content of the protocol, without an approved version", even if the protocol was approved later.

Known limitations

• Without a change to the permission matrix, the Audit screen and the Audit pack remain restricted to administrators, as before. A change to the matrix applies on screen after the page is reloaded.
• The text search on the Audit screen only applies to the rows on display and is not part of the CSV export; the other screen filters do apply.
• Changing the inactivity timeout does not yet require a reason or a signature, unlike compliance settings.
• The sections added to the PDF report (measurements, reagents, version statement) are not part of the report fingerprint.