Computerised system admin
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Can the Test Facility Manager be the admin for computerised systems?
RQA GLP Committee
This is possible, with care. Any changes that are made need to be clearly documented as to why. Therefore, if a user is being added or taken away, there should be a request in place that is then acted on and documented, giving the reasons for the change, and this can then can clearly be compared with the audit trail.
The manager should not be involved in the studies or have any involvement with data, and this should be easily visible from organisational charts etc, so that if the audit trail does indicate that the manager has been making changes to data it is obvious why.
Some companies have a manager of one area (i.e. Reproductive Toxicology) have responsibility for a completely separate area (i.e. Aquatic Toxicology). The main thing is that the manager has no interest (and is seen to have no interest) in the data.