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MDSAP Internal Audit Program example wanted


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internal audits, mdsap (medical device single audit program)
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  Post Number #1  
Old 9th January 2017, 07:05 AM
ago70

 
 
Total Posts: 2
Thank You! MDSAP Internal Audit Program example wanted

Hello

I am preparing the annual audit program. In preparation for MDSAP in 2018 I wanted to creat an audit program which is aligned with MDSAP requirements. My approach is alwas to have an effective and efficient audit program. But starting with my general approach (very good established) plus adding regulatory requirments according MDSAP will be not efficient. Also using the MDSAP 94 task from MDSAP seems not to be efficient.

Has anyody a best practice how to establish an internal audit program for MDSAP efficient an deffective? I don't want to add too much additonal ressources for internal auditing.

Looking forward for your ideas.

Kind regards,

Andreas

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  Post Number #2  
Old 11th January 2017, 05:52 PM
yodon

 
 
Total Posts: 853
Re: MDSAP Internal Audit Program example wanted

Your internal audit system should, as the standard indicates, "determine whether the quality system ... conforms to [the standard and applicable regulatory requirements] ... [and] is effectively implemented and maintained. The MDSAP audit, as I understand, will just take all the country-specific requirements into consideration as part of their audit.

The internal audit should already be considering your compliance to the applicable regulatory requirements so I'm not sure there should be all that much difference with your internal audit program when you transition to an MDSAP compliance audit.

That's my take. I hope others will weigh in with their thoughts.
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  Post Number #3  
Old 12th January 2017, 05:36 PM
Mark Meer

 
 
Total Posts: 513
Re: MDSAP Internal Audit Program example wanted

Have you taken a look at the MDSAP Audit Procedures and Forms available on the FDA website?

This might be a good starting point.

Quote:
Has anyody a best practice how to establish an internal audit program for MDSAP efficient an deffective? I don't want to add too much additonal ressources for internal auditing
Always remember that your internal audit program should have value to you. It should NOT be just a compliance exercise.

When planning your program, ask yourself: will this help drive improvement? In otherwords, is it effective at spotting non-conformances and opportunities for improvement?

MM
Thanks to Mark Meer for your informative Post and/or Attachment!
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