MDSAP Audit Questionnaire

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A

AndretN

Registered
#3
#3
Thank you - I have reviewed it from the FDA and also the one attached.
When one address all the requirements of MDSAP, would you cover all the regulatory requirements for each country e.g. Vigilance Contact Points, Incident Reporting, Record Keeping in your different SOP's?
 

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Y

yodon

Staff member
Super Moderator
#4
#4
You do need to address all the requirements ("what to do") in your QMS. The implementation details ("how to do") may be pushed down to lower-level docs or forms or something.
 
N

Nomnoms

Registered
#5
#5
yodon said:
You do need to address all the requirements ("what to do") in your QMS. The implementation details ("how to do") may be pushed down to lower-level docs or forms or something.
Click to expand...
From this - do you not consider the "how"/lower-level docs not part of your QMS? does that mean they are not subject to the audit?
 
Y

yodon

Staff member
Super Moderator
#6
#6
Nomnoms said:
From this - do you not consider the "how"/lower-level docs not part of your QMS? does that mean they are not subject to the audit?
Click to expand...
Yes they are part of the QMS. They *shouldn't* be subject to the audit (but I've seen auditors demand to see "how" things are done - which sparks a lively debate).
 
N

Nomnoms

Registered
#7
#7
yodon said:
Yes they are part of the QMS. They *shouldn't* be subject to the audit (but I've seen auditors demand to see "how" things are done - which sparks a lively debate).
Click to expand...
I am considering completely rewriting our procedures/instructions because there is too much "how" things are done which are not required to show compliance. It's also challenging because it's difficult for me to convince the departments to create more instructions to standardize the "how" as we grow as an organization because there is a belief that they are subject to audit.
For these 'lower-level' docs, how do you keep them separate from the audit? I was thinking that I should make sure there are no references in the procedures to them, but maybe only reference upwards from the "instruction". Any insight or suggestions?
 
Y

yodon

Staff member
Super Moderator
#8
#8
I don't "reference down" (no references to the WIs in the SOPs). I give the auditors the SOPs (and compliance evidence) and have yet had to pull up a WI.
 
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