21 CFR - Part 11 Compliance for GXP Documents

What is 21 CFR - Part 11 Compliance

The title 21 CFR [Code of Federal Regulations] PART 11 is a regulation act established by United States’ FDA [Food & Drug Administration] for electronic records and electronic signatures. This compliance defines the criteria under which the e signatures and Electronic records are considered equivalent to the paper records and the hand-written wet signatures. This regulation caters to the security concerns about the management, storage and retrieval of the electronic records and signatures by users of industries like biotechnology, pharma, and medical equipment manufacturers in this digital age.

Cygnature and 21 CFR Compliance

Cygnature being an electronic and digital signing tool, needs to fulfil the criteria to comply with the 21 FDA CFR regulations and Cygnature secures the workflow creation, signing and user authentication modules. This makes the signing process even more secure with multiple authentication layers and captures audit trails and timestamps of signing.

Features of 21 CFR - Part 11 Module

Access To Authorised Individuals Only

No Guest Access

Timestamped Audit Trail

Signer Authentication

Access Code Authentication

Signer Roles

Process flow for Signing 21 CFR - PART 11 Documents

Why Choose Cygnature for 21 CFR Compliance


Cygnature provides validation of systems to ensure accuracy, reliability, & consistent projected performance. It defines how elements of your system are supposed to work, then creates scripts and test routines to validate its functions. This process reassures the security of your data & audit logs.

Record Generation

According to Part 11 mandate your eQMS should have an indexing & search feature that allows you to search for records easily & quickly. Cygnature provides you with this feature where you search results showing all document changes and indicating the final version of the document.

Audit Trails

Cygnature is based on the Blockchain technology that provides secure, time-stamped audit trails recording the date, time, location of the entries and actions on the document. It gives you a clear picture of where you document was modified and when. This audit trail is generated automatically & is not modifiable.

Security Controls

Cygnature is Highly secured and does not allow any unauthorised person to make any alteration in the documents. It keeps a track of every version of the file while identifying those who made alterations in the past

Industries that can use the 21 CFR - Part 11 Compliance Module


Life Sciences

Medical Equipment Manufacturer