MDSAP Audit Plan - Please share an Audit Plan/Schedule/Agenda

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M

Maiar

#1
#1
Hello,
Has anyone had already an MDSAP audit?
Could you share the audit plan/ schedule/ Agenda?
Thanks
 
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Edward Reesor

Edward Reesor

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#2
#2
I was instructed by a very informed person (who will be performing audits) to go to this FDA link (.pdf) for the information on the audit . They plan on using this document for their own audit plan, step by step.

This and other documents can be found here.

It doesn't appear that anyone has a template you can use, but the links I have provided have several documents where templates may exist. Personally, I have been taking the lines from the linked document and adding it to my own Internal Audit tool.
 
C

cnpacs

Registered
#3
#3
You can google "MDSAP Documents", the first link is the FDA website for MDSAP. All MDSAP documents listed there.
MDSAP audit will follow process approach, with four primary processes:
1. Management;
2. Measurement, Analysis and Improvement;
3. Design and Development;
4. Production and Service Controls;
And a supporting process
• Purchasing
The MDSAP audit process has two additional supporting processes:
• Device Marketing Authorization and Facility Registration
• Medical Device Adverse Events and Advisory Notices Reporting.

Similar to US FDA inspection method.
 
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xcanals_tecno-med.es

xcanals_tecno-med.es

Involved In Discussions
#5
#5
Dear all

The audit plan depends on the organization as some tasks are applicable or not depending their activities (e.g. nos sterile devices --> task )
The tasks are reviewed following strictly the order established in the companion document and the total number of hours is calculated according the xls from MDSAP)

I attach a model of the plan used by a AO

Regards

:2cents:

Xavier Canals
 

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R

rmurp

Starting to get Involved
#7
#7
Highground, we are in the middle of an MDSAP audit. They are looking at our report and schedule and are not happy with it. They are expecting to see every element of the MDSAP companion document addressed in every audit we conduct internally. They also want to see time frames for each limit addressed in our agenda... I am so confused as I don't think much has changed in the style of auditing from the past expectations. Did you find the auditors wanting to see anything new in the audit schedule, plans and agenda?

thanks help! going crazy
 
H

Highground

Involved In Discussions
#8
#8
rmurp said:
Highground, we are in the middle of an MDSAP audit. They are looking at our report and schedule and are not happy with it. They are expecting to see every element of the MDSAP companion document addressed in every audit we conduct internally. They also want to see time frames for each limit addressed in our agenda... I am so confused as I don't think much has changed in the style of auditing from the past expectations. Did you find the auditors wanting to see anything new in the audit schedule, plans and agenda?

thanks help! going crazy
Click to expand...
The MDSAP companion document is mainly for the auditors. You only need to audit your QMS and the regulations you have approvals for your devices. Who is auditing you?
 
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