Part 11

Audit Trail Requirements Under Part 11

What Part 11 actually requires from an audit trail, and why database level enforcement matters more than application settings.

Electronic Signatures Under Part 11, Explained

What Part 11 requires from an electronic signature, and the difference between biometric and non biometric approaches.

Signature Manifestations Explained

What a signature manifestation is under Part 11, what it must display, and how it differs from the underlying signature record.

Part 11 Checksum and Tamper Evidence, What It Means

What tamper evidence actually means under Part 11, and how a checksum or similar mechanism supports it in practice.