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.

Related Articles

Data Integrity and Large-Scale Systems
iSpeak Blog
Data Integrity and Large-Scale Systems

This blog post will discuss the relationship between large systems that manage records at the multi-batch, multi-site level of operation and the data integrity of those records. There are several aspects to consider and they are specific to this type of environment. <

Article
iSpeak Blog
Data Integrity: Testing Into Compliance -- Without Trying!

As global regulators sharpen their focus on data integrity, issues have emerged around practices observed in operations that generate data used to make drug product decisions.  One such practice is “testing into compliance”-- repeatedly analyzing a sample until a desired result is obtained, then reporting this value while ignoring all previous values.  Regulators expect manufacturers...