Computerized System Validation (CSV) and Recent Trends

Computerized System Validation, or CSV, is a requirement of many regulatory bodies around the globe. There are many different guidance documents and industry white papers on the subject matter.

In this discussion I would like to provide a high level overview of what CSV is, how it is different from Qualification, why we need to do it, what are the benefits, and what are the new trends in validation to save cost and time while improving the value of the validation work that we do. CSV has long been considered a burden and an inhibitor to technology adoption. We will review some ways to incorporate these newer trends to improve our CSV paradigm, which will provide faster Time-to-Production and ROI for technology investments.

Presenter: Michael C. Korbel (Senior Compliance Consultant, Agilent Technologies)

Michael has over 24 years of experience in regulated environments in the Pharmaceutical and Bio-Tech industries. Half of Michael's career has been spent on the customer side of the industry in both IT and Laboratory positions; supporting, qualifying, and validating regulated computerized systems and instruments. The other half has been spent providing consultative compliance services from the vendor side of the industry. His experience includes supporting/validating both standalone and enterprise laboratory informatics systems, as well as instrument qualification, preventive maintenance, and relocation services. Michael has held various IT and Lab positions at MannKind Corporation and Purdue Pharma, as well as consulted for Pfizer, JnJ, and Merck. Michael has also held various positions at Waters Corporation, PerkinElmer OneSource, and Agilent Technologies. He currently serves as the Global Sr. Compliance Consultant on the Marketing team at Agilent Technologies. Michael holds a B.S. in Biology, with minors in Chemistry and Environmental Science.