Robert McDowall

McDowall Consulting
Director
Robert (Bob) McDowall, PhD, is an analytical chemist with over 50 years of experience, including 15 years working for two pharmaceutical companies, 30 years as a consultant, and over 35 years in CSV. Bob writes the Questions of Quality column for LCGC International and the Focus on Quality column for Spectroscopy. He edited the first book on a laboratory information management system (LIMS) and is the 1997 LIMS Awardee from the LIMS Institute. He has written two books on validation of chromatography data systems and one on laboratory data integrity. He also contributed to the ISPE GAMP® Guide: Records and Data Integrity and four ISPE GAMP® Good Practice Guides. He is the co-author of the USP : Analytical Instrument Qualifi cation’s current draft and the European Compliance Academy’s Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation. He joined ISPE in 1998.

Related Articles

blue-hexagon-background
Technical
Artificial Intelligence Governance in GxP Environments

Artificial intelligence (AI) is used by pharmaceutical and biotech companies, providing support from drug discovery through manufacturing. The nature of AI and concerns of bias, privacy, transparency, and security in a regulated industry necessitate a governance framework to ensure concerns are controlled using “guardrails.” These guardrails ensure the quality, privacy, and security of data...