Bound to the version
Training is generated from one exact source file version and stays tied to it. Each lesson highlights the passage it rests on, and the completion record names the version.
SEMANTIC FILE VERSIONINGSigned under Part 11
Re-authentication at completion, then name, timestamp and the meaning of the signature. Written to a log whose role holds INSERT and nothing else.
21 CFR PART 11Requalified with ease
A revision reassigns the new version to everyone whose group requires the document. Recurring requirements re-qualify on schedule. One nightly job runs both, idempotently.
NIGHTLY, IDEMPOTENTInside the training module
One training, taken apart. A controlled document becomes an assessment, what was missed comes back round, and the whole thing rolls up into a qualification.
- ·01Document sync
- SharePoint and Veeva Vault keep owning the controlled document. Credentials are encrypted AES-256-GCM.
- ·02Five question types
- Multiple choice, true/false, fill-in-blank, AI-graded short answer, ordered steps.
- ·03Retry to mastery
- Missed questions return in a retry queue until they are answered correctly. Two passes, one outcome.
- ·04Qualification matrix
- Role-based curricula, one-time or recurring, with a status per person and a drill-down by group.
Around every training
The controls a quality team asks for once the trainings are running.
- ·01What changed, first
- A training rebuilt for a new revision opens on a lesson about what changed, read beside the document.
- ·02A second person to publish
- Require that whoever generated or edited a training is not the one who signs it into publication.
- ·03Reminders you turn on
- Seven days and one day before a training falls due, and once when it is overdue. Each named manager gets one digest of what is newly overdue.
- ·04A manager reads their team
- Name any member as manager of their groups and they see who is overdue on what, read-only, without an admin's powers.