CFR 21 Part 11

Title 21 of the Code of Federal Regulations (CFR) Part 11, often referred to as 21 CFR Part 11, is a set of regulations established by the United States Food and Drug Administration (FDA). These regulations specifically pertain to the use of electronic records and electronic signatures in industries regulated by the FDA, particularly in the pharmaceutical, biotechnology, and medical device industries.

  1. Unique User Identification: Each individual using an electronic signature must be uniquely identified within the system. This typically involves assigning a unique user ID or username to each person authorized to apply electronic signatures.

  2. Authentication: The identity of the person applying the electronic signature must be verified and authenticated through appropriate means. Common authentication methods include passwords, biometric verification (e.g., fingerprint or retina scan), smart cards, or personal identification numbers (PINs).

  3. Electronic Signature Manifestation: An electronic signature should appear on the electronic record in a way that clearly associates it with the specific record and the individual who applied it. This could be in the form of a digital image of a handwritten signature, a typed name, or other methods defined by the organization's procedures.

  4. Signature Intent: The electronic signature must reflect the signer's intent to sign the electronic record. This means that the person applying the signature should be aware of and consent to the action of signing.

  5. Signature Controls: The system used to create electronic signatures must have controls in place to ensure that only authorized individuals can apply electronic signatures. This includes access control measures to prevent unauthorized access to the signature function.

To handle the above requirements, the admin can now enable the Reason and Location for eSignature which will direct the user to provide these details and enforce PIN authentication which can be configured as part of the Advanced Settings.

When the signatory opens the envelope to sign it, they will be prompted to insert the Location at which the envelope is signed, Reason for Signing the envelope.

The Signatory will then be prompted to provide the 6 digit pin before signing and finishing the envelope.

The Reason and Location this will be captured in the final signed document under the signature. The users can define their own PIN when they are using the signing application for the first time, and they also can reset it if they forgot.

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