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Audit Trail & Compliance Log

Immutable 21 CFR Part 11 audit trail across every module.

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Access anomalies

21 CFR Part 11 coverage

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System audit log

Timestamp	User	Action	Module	Record	Diff	IP
14:02:31	L. Romero · CRA	Modify	EDC	CRF-204-0124-VST3	ALT: 32 → 36	10.4.18.22
13:58:11	AI Filer · Agent	Create	TMF	TMF-2849-IRB-Charite	Document filed	127.0.0.1
13:41:02	R. Patel · Reg Lead	Sign	Regulatory	IND-128445	E-signature applied	10.4.22.91
13:18:44	M. Garcia · Monitor	Export	Quality	CAPA-204-009	PDF export	10.4.18.27

Electronic signature registry

IND-128445
Valid
R. Patel (Reg Lead) · Author approval · 13:41:02
hash: 0xa12f…91d
CSR-204 §11
Valid
Dr. K. Singh (Medical) · Medical review · 12:09:14
hash: 0x88a1…ce0
ICF-307-EN v1.3
Revoked
J. Tanaka (Legal) · Legal approval · Yesterday
hash: 0xb44d…71f

Access control audit

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Compliance issues

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Issue	Type	Severity	Record	Owner	Status
CI-118	Signature gap	High	ICF-307-EN v1.3	J. Tanaka	Open
CI-119	Access violation	Med	USER-447	M. Chen	Investigating
CI-120	Audit gap	Low	SUPPLY-LOT-9821	L. Romero	Open