Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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16 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m Quality: Validation C omputer system validation (CSV), also known as software validation, is required by regulatory agencies through- out the development timeline. Pharmaceutical Technol- ogy reached out to various experts associated with the FDA-Industry Computer Software Assurance (FISCA) team to discuss computer validation and add context to the ongoing discussion sur- rounding 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 PharmTech: What is the relationship between computer validation (as re- quired 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 completed purely for compliance and the benefit of auditors. The goal of CSA is to switch the focus during the CSV planning pro- cess. With CSA, additional inputs such as vendor audit results, system criticality, and additional upstream and downstream controls in the pro- Contexualizing Computer Validation Grant Playter Experts weigh in on the current state of computer validation and its role in the greater regulatory landscape. CYBRAIN - STOCK.ADOBE.COMW

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