Mark E. Newton Heartland QA

Mark Newton is a Pharmaceutical Quality professional with 37 years of experience in data integrity, LIMS, validation of computer systems, analytical systems, risk management, and quality systems, especially in the regulated laboratory space. He held roles in QC Labs, Computer Systems QA, Laboratory Informatics and QA during his 34-year tenure at Eli Lilly and Company. As an independent consultant since retiring from Lilly in 2018, He has assisted firms with forensic data reviews, good documentation practices, risk evaluation and process mapping to identify data integrity gaps and improve quality systems.

Mark has also been actively involved in ISPE/GAMP publications for a decade, co-editing to the GAMP Good Practice Guide for Computerized Laboratory Systems (2012) and writing for Records and Data Integrity Guide (2017) and Data Integrity-Key Concepts Good Practice Guide (2018) and GPG: Data Integrity by Design (2020) . He has also co-written articles with Robert McDowall on data integrity topics that have appeared in LC/GC Magazine.