Hi all,
our situation is the following:
we are administrating a lot of analytical equipement. we use an administrator shared account on each of these analytical equipement. the question is:
when we use these accounts there is no way to know who made changes (eg reset password of users). is it mandatory to know that ?
Thanks
Hi all
One of the major requirements in GMP is ACCOUNTABILITY.
When you hide behind a curtain of anonymity by using common signatures and passwords, you are in serious breach of the GMP requirements.
In my opinion a very serious breach.
Alex Kennedy
[quote=alexkennedy]Hi all
One of the major requirements in GMP is ACCOUNTABILITY.
When you hide behind a curtain of anonymity by using common signatures and passwords, you are in serious breach of the GMP requirements.
In my opinion a very serious breach.
Alex Kennedy
[/quote]
The administrators that use these shared accounts are documented in a list of user. the group is independant then the people performing analysis (users et supervisors). and these administrator do not produces any results !!! just administrating (creating user accounts, disbling accounts, reset password, configuring policies(documented in IQ/OQ)) …
Even if the admins are registered by using a signature page, a shared account for administrators is unacceptable because the administrators can change user passwords e.g. At that point you get in conflict with ERES.
What about the Audit Trail. If the equipment is GMP relevant, an Audit Trail has to implemented and the users as well as the admins have to be identifiable unambiguously.