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

GMP News No. 185

GMP News
04 April 2002

 NewFDA 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 CfrPart 11. According to FDA's Good Guidance Practices (GGP), this Guide isclassified as level-1 document. When the final version will have beenreleased, this document will represent FDA's current thinking "on computer-generated time stamps in ComputerSystems subject to Part 11." Comments can only be submitted until 18June 2002.

Time stamps are relevant e.g. in AuditTrails. According to 21 Cfr Part 11, time stamps are also required, amongother things, in the following cases:

  • Section 11.10(e) requires controls andprocedures to include the "[u]se of secure, computer-generated,time-stamped audit trails to independently record the date and time ofoperator entries and actions that create, modify, or delete electronicrecords ..." (emphasis added).
  • Section 11.50(a)(2) requires signedelectronic records to contain information associated with the signingthat clearly indicates, among other things, "the date and timewhen the signature was executed." (emphasis added). Section11.50(b) requires the date and time when the signature was executed tobe included as part of any human readable form of the electronicrecord (such as electronic display or printout).

Under 5.1.1. the Draft Guide stresses thefact that computer clocks have to be set correctly. It explains as anexample that computers on a network should automatically synchronize theirclocks (e.g. when logging on to the network). The network "masterclock" should itself be synchronized to a recognized standardcomputer clock.

It should be possible to detect changesmade to a computer clock. As well, there should be procedures "todetect and deter inappropriate changes to computer clocks." The Draftexplicitly recommends employee training as a means to put the requirementsinto practice. And it advises that the computer clocks should periodicallybe checked for unauthorised changes without prior announcement.

The Draft also takes up the problem oftime zones. Part 11 says:

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

This Guidance now suggests to establish areference to the time zone by including the reference in the time stamp.If this is not possible in the time stamp itself, the electronic recordshould be labelled in such a way that the reader knows immediately which timezone the time stamp refers to. In addition, time (e.g. 1330 hrs or1:30 pm) and date (e.g. 02/03/04 or 2 March 2004) must be expressed in away as to make sure that it is clearly understood.

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

Oliver Schmidt



Go back

GMP Conferences by Topics