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FDA CFR 21 Part 11 Primer
An overview of how TARE is designed to support controls relevant to FDA 21 CFR Part 11-style electronic records workflows.
TARE is designed to support controls relevant to electronic records, audit trails, review states, and electronic signatures. Customer SOPs, validation, training, configuration, and quality-system signoff determine regulated use.
Core Compliance Pillars
Audit History
Critical record actions can be captured in audit history. Customer configuration and retention policy determine which workflows require additional validation or review.
Electronic Signatures
When a protocol or dataset is finalized, it can be electronically signed. The signature is cryptographically bound to the specific revision of the data using SHA-256 hashes.
Configuring Approvals
- Navigate to Settings > Compliance Rules.
- Toggle Require Counter-Signatures if your workflow needs a secondary reviewer.
- Set up Authentication Timeout periods to force re-authentication during critical signing events.