Medical Device

FDA 21 CFR PART 11

WHAT IS FDA 21 CFR Part 11?

FDA 21 CFR Part 11 allows Medical Device and Life Science organizations to use electronic records and signatures in place of paper.
The regulation applies to all aspects of the research, clinical study, maintenance, manufacturing, and distribution of medical products, and covers:

  • 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

In order to meet these regulations, companies turn to software 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).

fda 21 - FDA 21 CFR PART 11

ITS BENEFITS

FDA 21 CFR Part 11 helps 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.
By becoming FDA 21 CFR Part 11 compliant, manufacturers will benefit from:

  • Reduced costs by removing manual and paper processes whilst improving workflow processes
  • Improved traceability - electronic records are simpler for gathering, filtering, and presenting information for internal use or FDA audits
  • The ability to print, reprint and reconcile labels at any time
  • Stronger controls over users’ ability to design, amend and approve labels
  • Better management of global data including product data, symbols, graphics, and languages

Download our whitepaper: Ensuring FDA Compliance: The Essential Guide to FDA 21 CFR Part 11