What is a CSV consultant?

A CSV Consultant in the pharmaceutical industry specializes in ensuring that computerized systems used in drug development, manufacturing, and distribution comply with regulatory standards. Their work involves validating that these systems operate as intended and meet stringent quality, safety, and data integrity requirements. This includes creating validation plans, protocols, and reports to demonstrate compliance with guidelines such as FDA 21 CFR Part 11, GAMP, and EU Annex 11.

A CSV Consultant plays a critical role in identifying risks associated with computerized systems and implementing controls to address them. They oversee testing processes, design test scripts, and ensure that software performs reliably and efficiently. Detailed documentation is another essential part of their responsibilities, providing evidence of compliance for regulatory audits and inspections.

With advancements in technology, CSV Consultants are now integrating modern practices such as test automation and agile methodologies into their workflows. These approaches help streamline processes, reduce repetitive tasks, and maintain compliance while enhancing system quality. The upcoming FDA guideline on Computer Software Assurance (CSA) is expected to further modernize these practices, shifting the focus from excessive documentation to ensuring systems are genuinely fit for purpose.

By combining technical expertise with a deep understanding of regulatory requirements, CSV Consultants ensure that IT systems in the pharmaceutical industry meet global standards, enabling safer and more efficient drug production.