White Paper

A Guide to implementing FDA-recommended Quality Metrics in 2022

Get the white paper delivered to your inbox when you submit this form

In recent years, FDA expressed interest in using relevant quality metrics for better planning their risk based inspections. This initiative started off with a Voluntary Phase and subsequently a revised draft guidance was published. Since the advent of this initiative a lot of feedback has been provided by the Industry, particularly its concern of additional efforts and expenses.

In this White Paper, we will be exploring what these Quality Metrics are, and how can one implement them. The contents of this White Paper include:

  • List & definitions of FDA-recommended Quality Metrics
  • Step by step methodoloy of implementing Quality Metrics
  • Example calculations of the following key Quality Metrics

Read case studies and see what we can do for your company.

No items found.