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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 electronic records and signatures by users of industries like biotechnology, pharma, and medical equipment manufacturers in this digital age.

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Purpose of 21 CFR Part 11 compliance

Part 11 applies to electronic records created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in Agency regulations.

To ensure only authorized users have access to the system and prevent unauthorized access

To prevent the data from being corrupted or lost

To maintain data security

To make sure that approvals cannot be repudiated

To trace changes to data through an audit trail

To detect and prevent any records from getting falsified

Cygnature and 21 CFR compliance

Cygnature provides a secure, workflow-based solution for managing electronic records and signatures. Designed according to industry best practices and regulatory guidelines, it is validated and certified by an FDA-authorized consulting agency in the USA. This ensures data integrity through advanced encryption mechanisms, safeguarding the data.

Features of 21 CFR - Part 11 module

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  • Enable / disable access rights for end user to use Cygnature
  • Configure the signature appearance for all end users as well as signers
  • Configure signing roles
  • Configure signing reasons
  • Access to entire Log activities for each end user (including login/logout activities)
  • Privilege to modify end user workflow i.e. the user admin will have access to their user(s) workflow and privilege to make changes in it like:
    • Signer’s actions: Change signer, send reminder, Access code, Add / Edit location, Set signer authentication
    • Document actions: Re-assign, Decline, Cancel, set a reminder, Extend due date
    • Attach supporting documents
    • Delete supporting documents
    • Download supporting documents
    • Add observers
  • Add activities for end-user change & reset password logs
  • Password configuration
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  • Provides secure access to users for uploading documents
  • Allows to set a role for each signer
  • Allows users to route documents for review and approval
  • Authenticates internal and external signers during review and approval process
  • Maintains timestamps and detailed audit trail
  • Signature contains the printed name of signer, the date and time when the signature is executed
  • Records the reason for signing on the document
  • Maintains repository of all documents
  • Provides additional security with access code

Why choose Cygnature 21 CFR Part 11 compliance?

Accuracy

To ensure that data is complete, truthful, and free from errors. Event performed by user should be easily and accurately retrievable through audit trails.

Traceability

To provide complete history with an audit trail and to identify what has changed and when.

Integrity

To ensure data integrity and reliability is maintained by ensuring there is no change in the data.

Availability

To ensure the accessibility of accurate data when required.

Accountability

To track a complete history and audit trail of the contributions in the process.

User Security

Only authorized individuals have access to data, adhering to the best industry-standard security protocols.

Data Security

Advanced encryption mechanisms to ensure secure data storage and retrieval.

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

Pharmaceutical companies

Pharmaceutical companies

Life science companies

Life science companies

Medical equipment manufacturers

Medical equipment manufacturers