Which rules apply?
EU AI Act
Reg. (EU) 2024/1689
Decision support only. A named person makes every decision.
EU GMP Annex 11
EudraLex Vol. 4
Audit trail, access control and electronic records.
21 CFR Part 11
FDA
Signatures with name, time and meaning of signing.
GAMP 5
2nd Edition
Risk-based validation support for the customer's CSV team.
GDPR
Art. 5, 6, 9
Minimal capture, consent and redaction of people in view.
How is it controlled?
Human oversight
- Brain proposes, never closes a deviation
- Findings stay INFERRED until signed
- QA / QP holds final authority
ALCOA+ data integrity
- Every claim cites a source record
- Uncited statements are discarded
- Original records are never edited
Audit trail
- Who did what, when, and why
- Append-only, time-stamped
- Exportable for inspection
Change control boundary
- Expert knowledge never edits an SOP
- Held as unvalidated until QA review
- Released only via formal change control
Audit trail · BR-204 investigation
SIMULATED · AUD-2026-9142- 17 Sep 2026 · 14:37:12System (SCADA) — Alarm TT-204 high recordedKNOWN
- 17 Sep 2026 · 14:52:40J. Müller · Technician — Observation added to investigationOBSERVED
- 17 Sep 2026 · 15:10:03NeoFabrik Brain — Finding drafted · 4 records citedINFERRED
- 17 Sep 2026 · 15:31:55Brain citation check — Batch genealogy not establishedUNKNOWN
ALCOA+ check · cited records
Attributable
Legible
Contemporaneous
Original
Accurate
Complete
Consistent
Enduring
Available
Cleanroom privacy
Smart-glasses sessions capture the machine and the technique — designed to blur faces, badges and unrelated speech before storage.
Can the AI change a procedure? No.
Expert capture
Unvalidated knowledge
QA review
Change control
SOP v2.0 released
