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 trials and timestamps of signing.


Features of 21 CFR - Part 11 module

Provide access to authorized individuals only (no guest access) as per 21 CFR 11.10 (d)
Record a computer-generated time-stamped audit trail as per 21 CFR 11.10 (e)
Signature appearance with name of signer, date, and time of signing and the reason for signing as per 21 CFR 11.50
Authenticate the signer while applying for the signatures as per 21 CFR 11.200
Use access code in combination with password as per 21 CFR 11.300

Process flow for signing 21 CFR - PART 11 documents

Process flow dia

Why choose Cygnature for 21 CFR compliance?

Industries that can use the 21 CFR - Part 11 compliance module

Pharmaceutical companies
Life science companies
Medical equipment manufacturers

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