Computer access, password control

duff999

Involved In Discussions
#1
Hi Folks

I'm finding a wealth of information form this forum and appreciate all the feedback from my other postings.

I have developed an SOP called Preservation of Electronic Data / Information Technology - Question came up about access rights / passwords to computers in the lab that are multi use.

Is the SOP I stated above the appropriate place to state the policy, or would a different SOP be the best place for this to live, perhaps Infrastructure?

thoughts?
 
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yodon

Staff member
Super Moderator
#3
There's no "more right" place for specific information. What you describe is effectively all part of document / record control (data integrity). Effectiveness is far more important than where you document something. Answering the question posed by @Ed Panek might lead you to what works best for your company.
 

duff999

Involved In Discussions
#4
The question came up during a supplier audit questionnaire. Since the question was raised I wanted to be sure I was capturing this somewhere in our documentation.
 

Tidge

Trusted Information Resource
#6
It is common for Medical Device manufacturers to maintain (often within the Quality Manual) a matrix of how various clauses from different regulations and standards are satisfied (and where to find such things). Perhaps your QM requires an addition for 21 CFR 11? The system you describe sounds like an OPEN SYSTEM.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
As mentioned above its best to document it where the people with the need to know are most likely to read it. If its high-level info maybe the quality manual is the right place. If its very specific it could be on a form or SOP for that specific use case. Just make sure you know who needs to know it and they signed training that they read it somewhere. For a very deep understanding we wrote a short open book quiz for certain info

As @Tidge mentions, during an audit its important to know where the requirements are met in your system. If an auditor asks a question you may respond "Are you looking for evidence of 8.3.3 of ISO XXX?" This way you just look at your matrix and know which document(s) to show.
 
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