New FDA Guidance on 21 Cfr Part 11 - »Time Stamps«

GMP News No. 185
GMP News
04 April 2002

 New FDA Guidance on 21 Cfr Part 11 - 
»Time Stamps«

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:

  • Section 11.10(e) requires controls and procedures to include the "[u]se of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records ..." (emphasis added).
  • Section 11.50(a)(2) requires signed electronic records to contain information associated with the signing that clearly indicates, among other things, "the date and time when the signature was executed." (emphasis added). Section 11.50(b) requires the date and time when the signature was executed to be included as part of any human readable form of the electronic record (such as electronic display or printout).

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:

  • "[R]egarding systems that may span different time zones, the agency advises that the signer's local time is the one to be recorded."

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:

No. Date Title Location
14-16 May 2002 GMP Compliance for Computer Validation Hamburg, Germany
19-20 June 2002 Electronic Records/Electronic Signatures - Implementation of 21 CFR Part 11 Frankfurt/Main, Germany

If you would like to read the details, you can download the Guide via this link.

Oliver Schmidt


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