Good Validation Practice (GVP)

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Introduction

During the 2011 PhUSE conference a Validation Discussion Club will take place. Results from the discussion club will be captured on the PhUSE Wiki. The goal is to define and appraise the various validation tools, techniques and processes employed in the healthcare industry and to collaboratively develop best practice guidance on how to select the optimal validation strategy for single use programs which report and analyse clinical data.

We want to

  • Identify the key methodologies regularly used in validation, and define standard terminology
  • Discuss the pros and cons of each validation method in various scenarios
  • Share experience around validation documentation
  • Consider FDA perspective around validation

(moved from previous PhUSE Wiki, original Author: Dirk Spruck)

SaschaAhrweiler 13:44, 21 March 2012 (CDT)