Re: Aged Inspection Equipment Software has no Audit Trail - Validation of Software
Some general remarks:
There is no yes or no answer for such a general question / problem.
There are always multiple ways to Rome (and compliance)
Regarding your problem:
What is the process this software fullfills? (is it a register, a digital quality or product file, a software design tool, etc..)
(or is it just a registration tool such as excel, word, access?)
What is the criticallity of this process? (do you base descisions on the outcome, if so how critical are these, etc...)
Is the process so critical that the input (in the software) should be restricted to qualified personell only? (Please note that this can be done in multiple ways other than log-in restrictions on the software itself, e.g. OS log-in / application restrictions, network access restrictions, area restrictions, etc...)
Is the output critical? (who may access the output, can it be altered (accidentally), ...)
Is the output digital or do you keep hard copies (paper) as original files.
Long story short:
How critical is this software in your production process and what is the nessesity to control user access?
Hope this helps a bit.
Doubt is not a pleasant condition, but certainty is absurd.
Voltaire (1694 - 1778)