DekEn

อัปเดต 2026-09-07

Tamper-evident audit trail

HMAC-signed · 21 CFR Part 11

A tamper-evident, HMAC-signed audit log of every study action — filterable and load-more in a viewer with a live chain-integrity verify badge, exportable per-study or, for an org admin, streamed as a cross-study CSV — so the record of who changed what and when holds up to scrutiny under 21 CFR Part 11-style practice.

เมื่อไรจึงใช้
  • An auditor or regulator asks to see the change history behind a safety study's numbers.
  • An org admin needs a compliance-wide export of audit events across every study, not just one.
  • Verifying that a study's history hasn't been silently altered.
ค่าที่ต้องกรอก
ค่าคำอธิบาย
HMAC signing keyServer-held key (AUDIT_HMAC_KEY) that signs every event — rotating it without a chain-migration plan falsely 'tampers' all prior evidence.
คำนวณอย่างไร

Every capturable action (unit-of-work database operations) is signed with an HMAC chained to the prior event, so the verify endpoint can detect any after-the-fact edit to the log itself, not just to the study content.

ข้อควรระวัง
noteAudit capture scope is honest-by-doc: it covers unit-of-work operations, not every conceivable read; a bulk delete is evidenced by its parent operation's event, not a separate row per child.
ที่เกี่ยวข้อง