Medical Device

What is FDA 21 CFR PART 11

FDA 21 CFR Part 11 allows medical device and clinical trial organizations to use electronic records and signatures in place of paper-based documentation under certain criteria.

The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and details:

  • Required records that are maintained in electronic format in place of paper format
  • Required records that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities
  • Records submitted to FDA in electronic format
  • Electronic signatures that are intended to be the equivalent of handwritten signatures


FDA 21 CFR Part 11 can help organizations reduce the cost of managing and documenting their entire labeling lifecycle, from routing and approval workflow, version control and comparison, to audit trails and reports.

To ensure compliance, many companies turn to software vendors to help bridge the gap. But a piece of software by itself cannot be compliant. Any critical software must be supported by a properly conceived and performed validation project, normally following GMP (as show below).

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A validated FDA 21 CFR Part 11 compliant system will improve workflow processes and reduce costs by removing manual and paper processes. Electronic records will also provide easier traceability as they are simpler for gathering and filtering to present information for internal use or FDA audits.


The PRISYM 360 cloud-based labeling solution was purpose-built for use in the medical device and clinical trial industries and designed from the outset to support the use of electronic records, electronic signatures and audit logging, simplifying FDA 21CFR part 11 compliance:

  • All data and actions are stored as Electronic Records that cannot be subsequently changed or deleted.
  • Records can be exported in electronic format or transformed into human readable copies.
  • The username, date and time and reason are captured and logged for all activities requiring e-signature verification.
  • Comprehensive version and revision control applies to every data component. Changes to approved entities will automatically increment the version number, be marked as subject to approval, and added to the audit log.

GAMP® 5, a managed risk-based approach to validation, which is likely to form the basis of the FDA’s forthcoming Computer Software Assurance (CSA) regulations, explicitly directs regulated organizations to leverage the expertise and documentation of the software vendor. Each release of the PRISYM 360 global labeling system is supplied with a full validation documentation pack to reduce your compliance burden and accelerate the validation process, including necessary information that allows you to fulfil your PQ testing obligations.

For further guidance on ensuring compliance with FDA 21 CFR Part 11, please download our whitepaper: Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11

This article was published on June 5th, 2021