Ombu Enterprises LLC Ombu Enterprises LLC   
 
 
 
  MDSAP Audit Times Reduced

In an October 31, 2017 notice, Health Canada that says the MDSAP Consortium has implemented changes to reduce the audit time. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/activities/international/single-audit-program-reduction-audit-times.html

 

The changes include:

·         Streamlined the MDSAP audit approach in the revised version of the audit model. This has reduced the total number of tasks to be accomplished and reduced the overall audit time

·         Introduced a 10% reduction in audit time for manufacturers with 45 or fewer employees

·         Introduced a 20% reduction in audit time for manufacturers with 15 or fewer employees

·         Introduced a 20% reduction in the duration of surveillance and re-certification audits for all manufacturers

·         Clarified the expectations for annual surveillance audits with the goal of reducing the audit time.

 

 

 
 
 
 
© 2017 All Rights Reserved.