Transitioning from CSV to CSA for a Biotechnology Company
Clarkston Consulting recently partnered with a biotechnology client in their transition from CSV to CSA. Read a synopsis of the project below or download the full case study.
Download the Transitioning from CSV to CSA Case Study Here
The client is a leading biotechnology company with a portfolio of medications across multiple diverse therapeutic areas designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases, and rare diseases.
The client engaged Clarkston Consulting to help move from a traditional Computer System Validation (CSV) approach to a Computer Software Assurance (CSA) approach to comply with the FDA draft guidance on ‘Computer Software Assurance for Production and Quality System Software.’ The client was also looking at performing a validation for several Veeva modules and saw the opportunity to consider modifying their process to include elements of CSA in order to streamline the process while still ensuring verification of appropriate fitness for use.
The project began with the Clarkston team reviewing the current CSV processes to identify areas of opportunity to simplify processes and align with industry best practices, including CSA. The focus on intended use and identification of high-risk in the end-to end process areas utilizing real life testing scenarios enabled the team to streamline the documentation, training, and testing requirements. The team authored new Standard Operating Procedures (SOPs) needed to implement the use of CSA. Training materials were developed and used to train the existing CSV team and identified business users on the new concepts of CSA and how to implement them. The team also developed protocols for Veeva validation using CSA principles. Throughout the process, Clarkston utilized Organizational Change Management (OCM) principles to provide support and help ease the transition from CSV to CSA.
As a result, the client was able to implement the current best practice CSA principles and risk-based evaluations to update and streamline their validation processes while still ensuring their systems have appropriate fitness for use.
