21 CFR Part 11 explained

21 CFR Part 11 is a set of regulations by the FDA (Food and Drug Administration) that govern electronic signatures and electronic record maintenance.

It details how FDA regulated organisations (in the USA) that like to move away from paper-based documents and ink signatures, can be compliant using electronic quality records and digital signatures.

CFR stands for Code of Federal Regulations that include rules and regulations published by the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 includes all regulations for the Food & Drug Administration, while part 11 refers to Electronic Record and Electronic Signatures.

21 CFR Part 11

21 CFR Part 11 details three main considerations:

  • Secure User Identification
    To be compliant, systems must have secure user access. It is essential users have unique usernames and passwords, to make sure it is always clear who is operating the system. Secure user identification also enables organisations to detect and prevents unauthorized access to systems.
  • Audit Trail
    To be compliant, organisations need to be able to provide an audit trail of all records of all operations. Systems need to be capable of storing data against all user activity, protect reports from being edited or deleted and enable safe interaction with other systems.
  • Electronic Signatures
    To be compliant, systems need to be able to assign electronic signatures to each individual user. To be legally equivalent to a binding ink signature, each electronic signature needs to be certified in writing by the owner of the signature.

Using a leak detection system that supports compliance with 21 CFR Part 11 not only makes the instrument qualification and operational qualification (IQ/OQ) processes more efficient, it also facilitates the scale-up of new products.

All Sepha leak test solutions including the VisonScan 3D, VisionScan Max, Multi-Q, PakScan and MediScan can form part of 21 CFR Part 11 compliance.

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