Executive Director, Computer Systems Quality & Data Integrity
Michael Rutherford is Executive Director, Quality Assurance, Computer Systems Quality and Data Integrity at Syneos Health. In this role, he is responsible for computer systems quality and working with colleagues across the company to create and implement a Syneos Health data integrity program. Mike retired from Eli Lilly and Company in 2017 after a 29+ year career, where he held numerous technical, administrative, and operational leadership roles within the Laboratory, Quality, and Medicines Development Unit. Mike is recognized as a global technical expert in ER/ES, data integrity, computer systems validation and quality, as well as laboratory automation and laboratory informatics. Mike has been involved with ISPE and GAMP® since 2003. He currently serves as Vice-Chairman on the ISPE International Board Executive Committee and as a Board member for the ISPE Foundation. He is a member and Past Chair of the GAMP CoP Global Steering Committee and a sponsor of numerous GAMP Special Interest Groups (SIGs), including those on Data Integrity and the Cloud. He has organized and chaired numerous ISPE and GAMP related conferences and was the 2019 ISPE Annual Meeting Chair. Mike received the 2014 ISPE Max Seales Yonker Member of the Year Award and the 2016 ISPE Joseph X. Phillips Professional Achievement Award. Mike has a BS degree in Chemistry from Delaware Valley University, and an MS degree in Analytical Chemistry from the University of Kentucky.
Where has 2023 gone? The year is already three-quarters over. The 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada, is just a few weeks away. And I will be...
It is hard to believe that by the time this column is published, my term as Chair will be half over. We’ve accomplished much, and I’m left wondering, “Where has the year gone?”
2023 continues to move right along—the first quarter is almost over. I remain very optimistic about this year as ISPE International, with support from the International Board, continues to make progress on our 2023 objectives and the 2023—2025 ISPE Strategic Plan.
As we head into 2023, it is hard to believe that it has been four years since the COVID-19 pandemic started to impact our lives and transition us to a new normal. It is also amazing how much technology and innovation continued to advance in those four years to allow our industry to develop new vaccines and innovative products to meet the world’s challenges.
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation-driven approaches.