Requirement of Pharmacovigilance (Drug Safety) Risk Based Strategic and Tactical Audit Plan

#1
Hello,
I am Quality Assurance auditor for Pharmacovigilance (drug safety).
As per European Union Good Pharmacovigilance Practice (GVP) Module - 4; pharmaceutical company need to to perform risk based audit of their pharmacovigilance systems and its quality systems. For this Strategic and tactical audit plan has to be prepared using risk based approach.
Please let me know if any one has idea on how to develop these audit plan. If anyone has the template of such documents please share for the reference purpose.

Thank You
Deepak
 
Elsmar Forum Sponsor
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