Background:

The current Computerized System validation (CSV) process for a large Pharmaceutical company was relatively young and had undergone modifications. Given changes in the business, PPT was engaged to perform a review of the current CSV approach to ensure it could provide regulatory compliance, suitability for purpose, and ease of use. The CSV methodology needed to be in harmony with an “off the shelf” approach to software selection, while ensuring regulatory compliance and ease of use. PPT completed an comprehensive document that provided the client with the analysis results and recommendations for process improvements in this area.

Goals:

Review the existing CSV policies for compliance with FDA regulations, guidance documents, and industry best practices
Interview persons involved in validation deliverables to identify potential process improvements
Review validation packages developed under the current CSV practice to identify potential process improvements
Assess the current approach to ensure level of effort and deliverables are appropriate for all GxP relevant CSV efforts
Prepare a report of the CSV process assessment identifying areas of excellence, areas of potential improvement, and areas that must remain static to ensure regulatory compliance

Accomplishments / Benefits:

Development of a comprehensive Analysis and Recommendations document that detailed areas for improvement as outlined above
Development of an actionable Roadmap that identified and prioritized initiatives that directly address the areas for improvement
Creation of a set of validation approach models to address unique application complexity levels
Knowledge transfer of industry and IT best practices to both IS and business leaders, creating a new understanding for future GxP relevant CSV efforts.