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8 BioPharm International Quality and Regulatory Sourcebook eBook March 2022 www.biopharminternational.com Contextualizing Computer Validation Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape. C omputer system validation (CSV), also known as software validation, is required by regulatory agencies throughout the development timeline. BioPharm International reached out to vari- ous experts associated with the FDA-Industry Computer Software Assurance (FISCA) team to discuss computer validation and add context to the ongoing discussion surrounding its use and importance in the greater regulatory landscape. Individuals responding for comment include: • Ray Murphy, Fellow Software QA Engineer, Boston Scientific • Ken Shitamoto, Sr. Director IT QE, Gilead Sciences, • Marc Koetter, Senior Manager CSV, Fresenius Medical Care • Lou Poirier, Program Director, Quality Systems, Insulet • Ron Schardong, Sr. Director Technology Quality, Johnson and Johnson • Jason Spiegler, Sr. Director Life Sciences Strategic Initiatives, Siemens Digital Industries. VALIDATION AND ASSURANCE BioPharm: What is the relationship between computer val- idation (as required by regulatory agencies) and computer software assurance (CSA)? FISCA: CSA can be seen as the element within CSV that ensures that the validation effort is correctly sized for the system under test. It ensures that CSV is a process that adds value for manufacturers, rather than a one size fits all activity that is completed purely for compliance and the benefit of auditors. Traditionally, when scaling validation efforts, inputs to the planning process were somewhat limited to whether the system was custom or 'off the shelf ', which could lead to GRANT PLAYTER Quality and Regulatory Sourcebook Quality: Validation Cybrain - Stock.adobe.com