Mark E. Newton
Heartland QA LLC
Owner
Mark Newton is an independent consultant in data integrity, 21CFR11 application, validation of computer systems/spreadsheets, analytical instruments and LIMS/ELN. He has 30+ years of pharmaceutical experience in data integrity, computer systems QA, analytical instrument qualification and lab informatics. Mark co-lead Eli Lilly’s data integrity remediation program for QC Labs worldwide in 2012, consulted and audited several Lilly sites preparing for data-integrity focused inspections. He is a co-leader for the GAMP Data Integrity SIG and Chair of ISPE Global Documents Committee. He began consulting in 2018 and has done data integrity governance and procedures, forensics and assessments/remediation and training courses for several companies in pharmaceuticals/ATMP markets.
