Lessons Learned From Implementing The FDA's CSA Guidance: Planning

By Brian Stephens, Assistant Director, CSV

Explore some of the bumps and challenges that some drug manufacturers have faced while working to meet the latest Computer Software Assurance (CSA) guidance drafted by the FDA. This guidance has been used to reduce the effort and cost required to complete two large computer system validation projects. This article describes the lessons learned during the planning stage of the project that help alleviate the growing pains associated with changes made to the tried-and-true validation process that most companies are familiar with.