We’ve launched a new 21 CFR Part 11 module to help organisations that must meet U.S. FDA electronic records and signatures requirements. The module is available now in Annature and is designed to make it straightforward to collect signatures that align with Part 11 expectations.

What’s new

• Part 11 signature field — a dedicated field type you can add to any document. When used, the field requires recipients to authenticate themselves before signing and records a tamper-evident audit trail tied to that signature.

• Auditability and controls — signatures captured via the Part 11 field include the metadata and controls organisations need to demonstrate signature integrity, traceability and accountability.

• Availability — the module is available now for all accounts and is enabled by default.

Who this is for

This is aimed at FDA-regulated organisations and any team that needs a higher-assurance signature workflow: life sciences, medical device manufacturers, clinical research organisations and regulated healthcare providers. It’s built to make compliant signing easier without forcing teams into awkward manual processes.

How this helps

Using the Part 11 signature field gives you a signing flow that enforces recipient authentication, produces a clear and auditable record, and reduces the manual work needed to produce regulatory evidence. In short: stronger authentication, clearer audit trails, and less paperwork.

We’ve also introduced a new Stamp field — a regulation-friendly visual stamp that many overseas regulators have requested. The Stamp field complements the Part 11 signature by adding a visible regulatory element to signed documents.