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21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

Issued by the FDA in 1997, the 21 CFR Part 11 final rule is intended to permit the widest possible use of electronic technology.  This is divided into two main sections:

Electronic Records

Electronic records are natural extension to the traditional use of paper records. Paper records mainly provide data security and can carry handwritten signatures to indicate that certain data is correct. Attempted corruption of either the data or signature is readily detectable. Electronic Records are required to provide secure data which can provide a high level of confidence. Outlining its value, here are some advantages of using electronic records.

  • Secure process values and audit trials (alarms, events, operator actions, log-in/log-out, operator notes, electronic signatures)
  • Protection of data through compressed, binary and check-summed records
  • Accurate time stamps are fortified using automatic time synchronization to a known clock source
  • Provision for electronically copying data for archive
  • Export facility providing visibility of secure records in readable form

Electronic Signatures

Electronic signatures are popular because they are easy to use. Customers can sign documents online with a click of the mouse or by using their fingers to trace a handwritten signature onto a document. The downfall of electronic signature is that they aren’t regulated like digital signatures are. It’s up to each vendor to make their own standards. Below mentioned are the advantages of electronic signatures.

  • All user actions can be configured to require signing or authorization
  • User specific access according to authority level
  • Signature element controls unique user signature, password expiry, minimum password length, automatic log-off, automatic disabling and notification of failed login attempts
  • Ensuring unique users by retiring and not deleting accounts

Electronic signatures require both operators and supervisors to identify themselves electronically in such a way as to be equivalent to handwritten signatures. This also allows the use of biometrics such as fingerprint or retinal scan devices. The advancement in electronic systems offers significant benefits for data retrieval and storage of data. FDA developed the 21 CFR Part 11 rule to describe what they require for securing the electronic records and signatures.

Complying with FDA 21 CFR Part 11 is critical for organizations. How are you aligned with the same? To know more, reach out to us @ sales@freyrsolutions.com.