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:
If you would like to read the details,
you can download the Guide via
this link.
Author:
Oliver Schmidt
CONCEPT HEIDELBERG
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