Validation in a Resource Limited Environment – A Strategic Approach

Authors

• M Holdsworth
• M Duvenhage
• C Lassnoff
• J Sun
• K Newell
• C Whalen
• M Tartakovsky

Abstract

Over the past 17 years, since the FDA first published their 21 CFR part 11 predicate rules, regulations and best practices have increasingly emphasized the importance of comprehensive documented system validation. Such validation, by its very nature, is a resource intensive activity. While everyone in the Clinical Research environment accepts and values the necessity of system validation, very often, smaller organizations, non-corporate organizations, governmental institutions, non-profit organizations and academic institutions simply do not have the necessary resources to perform a comprehensive documented validation following a traditional approach. The international Clinical Research Data Services team (working for the NIAID's Office of Cyber Infrastructure and Computational Biology), consequently, developed a strategic, “resource lite”, approach to system validation that involved the following strategies: • Combined User group initiated vendor audits • Detailed Validation risk analysis • Critical risk driven validation • Reduced documentation • Targeted training • Emphasis on “Ongoing Validation” While it is very difficult to quantify the difference (in resource utilization) between a “classic validation approach” and a “strategic validation approach”, it was apparent to our team that a strategic validation approach allowed us to complete a full system validation (with limited resources) and still adhere to regulations and best practices.

Scientific Focus Area: Research Support Services

This page was last updated on Friday, March 26, 2021