Understanding FDA 21 CFR Part 11

21 CFR Part 11 final rule is intended to permit the widest possible use of electronic technology.

Issued by the FDA (Food & Drug Administration) 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 Signatures

These are a natural extension to the traditional use of paper records. Paper records provide data security and can carry handwritten signatures to indicate that certain data is correct and log events, which took place. Attempted corruption of either the data or signatures is readily detectable.

In basic terms the requirement of Electronic Records is to provide secure data which can provide a high level of confidence as would be the case with paper records. Electronic signatures require that both operators and supervisors can electronically identify themselves in such a way as to be equivalent to handwritten signatures. The rule also permits the use of biometrics such as fingerprint or retinal scan devices.

The advance in electronic systems offers significant benefits for data retrieval and storage of data. The FDA developed the FDA 21 CFR Part 11 rule to describe what they require to be comfortable that the electronic records and signatures are secure.

FDA 21 CFR Part 11 Made Easy!

From plant wide data access security management to single, secure recorders – let us help you choose a solution that is right for you.