# Product Requirements

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### PRD-00001: Electronic Signatures

**Level**: PRD | **Status**: Active

The system SHALL support electronic signatures compliant with FDA 21 CFR Part 11.

**Acceptance Criteria**:
- Signature includes user ID and timestamp
- Signature is cryptographically bound to signed content
- Signature meaning is captured

*End* *Electronic Signatures* | **Hash**: 9ead6ee0
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### PRD-00002: Audit Trail

**Level**: PRD | **Status**: Active

The system SHALL maintain audit trails for all data changes.

**Acceptance Criteria**:
- Who, what, when captured for every change
- Audit records are immutable
- Audit trail available for inspection

*End* *Audit Trail* | **Hash**: 85ebed06
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