04 April 2002
FDA Guidance on 21 Cfr Part 11 -
On 12 March, the FDA published the meanwhile third interpretation guideline (see our GMP News of 9 October 2001 for preceding guidances) on 21 Cfr Part 11. According to FDA's Good Guidance Practices (GGP), this Guide is classified as level-1 document. When the final version will have been released, this document will represent FDA's current thinking "on computer-generated time stamps in Computer Systems subject to Part 11." Comments can only be submitted until 18 June 2002.
Time stamps are relevant e.g. in Audit Trails. According to 21 Cfr Part 11, time stamps are also required, among other things, in the following cases:
Under 5.1.1. the Draft Guide stresses the fact that computer clocks have to be set correctly. It explains as an example that computers on a network should automatically synchronize their clocks (e.g. when logging on to the network). The network "master clock" should itself be synchronized to a recognized standard computer clock.
It should be possible to detect changes made to a computer clock. As well, there should be procedures "to detect and deter inappropriate changes to computer clocks." The Draft explicitly recommends employee training as a means to put the requirements into practice. And it advises that the computer clocks should periodically be checked for unauthorised changes without prior announcement.
The Draft also takes up the problem of time zones. Part 11 says:
This Guidance now suggests to establish a reference to the time zone by including the reference in the time stamp. If this is not possible in the time stamp itself, the electronic record should be labelled in such a way that the reader knows immediately which time zone the time stamp refers to. In addition, time (e.g. 1330 hrs or 1:30 pm) and date (e.g. 02/03/04 or 2 March 2004) must be expressed in a way as to make sure that it is clearly understood.
If you are looking for further information on 21 Cfr Part 11, we recommend you the following seminars:
If you would like to read the details, you can download the Guide via this link.