Inspectors rarely ask you to define ALCOA+. They ask you to show it: who entered this value, when, what it was before, and why it changed. A well-configured EDC answers those questions without a spreadsheet on the side.
The principles, mapped to the system
| Principle | What to verify in the EDC |
|---|---|
| Attributable | Unique user accounts, no shared logins, role-based access; every entry carries the user ID. |
| Legible | Values readable for the record's full retention period, including exports and archives. |
| Contemporaneous | Server-side timestamps (UTC with site offset), not client clocks. |
| Original | Source documents or certified copies identified; eSource fields flagged. |
| Accurate | Edit checks, range checks and query workflow validated against the DVS. |
| Complete | Audit trail retains every version; deletions are logical, never physical. |
| Consistent | Same date/time conventions and sequence across forms and exports. |
| Enduring | Backups, restore tests and archive formats (e.g. PDF/A, XML) defined. |
| Available | Records retrievable for monitoring, audit and inspection within agreed timelines. |
Audit trail: the 21 CFR Part 11 expectation
Part 11 §11.10(e) asks for secure, computer-generated, time-stamped audit trails that independently record the date and time of entries and actions that create, modify or delete electronic records, without obscuring previously recorded information. In EDC terms, confirm that:
- Old and new values, user, timestamp and reason for change are captured for every edit.
- Users cannot edit or disable the audit trail, including administrators.
- The audit trail is exportable in a human-readable form for inspection.
Electronic signatures
Signature manifestations should show the printed name, date and time, and the meaning of the signature (for example, “Investigator approval”), and each signature must be linked to its record so it cannot be copied to another (§11.50 and §11.70).
Validation tests worth adding
- Edit a locked form as each role and confirm the expected denial is audited.
- Change a value twice and verify both prior values remain visible.
- Change the client clock and confirm stored timestamps do not move.
- Restore last night's backup to a sandbox and compare record counts and hashes.