MDSAP Audit Approach 2020

[Kavi_94]

Hi everyone,

I was wondering if anyone can help me have an overview of the new MDSAP Audit Approach released in September 2020. And the critical changes or impact for the Brazilian market.

Thank you

 

[Robyn W]

Hi everyone,

I was wondering if anyone can help me have an overview of the new MDSAP Audit Approach released in September 2020. And the critical changes or impact for the Brazilian market.

Thank you

You can get the document MDSAP AU P0002.005 Policy Title: MDSAP AUDIT APPROACH from the FDA website. I could not put the link in as I have not posted enough times.

 

[MHWinter]

The document includes a Summary of Changes from Prior Revision at the end.

 

[Ajit Basrur]

You can get the document MDSAP AU P0002.005 Policy Title: MDSAP AUDIT APPROACH from the FDA website. I could not put the link in as I have not posted enough times.

Link attached: MDSAP Audit Procedures and Forms

 

[perkinsmark83]

What I find interesting is that they seem to flip flop between having a companion doc an not having a companion doc. The most current posting at the FDA site is MDSAP AU P0001.006 released April 1, 2021 and there is no companion doc with it. They had integrated the companion doc in an earlier version, then created a companion doc again...