Bob McDowall is an analytical chemist with 50 years of experience, including 15 years working in the pharmaceutical industry, followed by 29 years working for the industry as a consultant. He has over 35 years’ experience in automating laboratories and computerised systems mainly within involving analytical systems and laboratory informatics. Bob edited the first book on Laboratory Information Management Systems (LIMS) in 1987 and he is the 1997 LIMS Awardee from the LIMS Institute presented for advances and training in the subject.
He was a co-author of the revision of USP <1058> on Analytical Instrument Qualification that integrated instrument qualification and computerised system validation that was updated in 2017. Bob has also been involved with the validation of computerized systems for over 30 years and is the author of Validation of Chromatography Data Systems, 2nd Edition published in 2017. His latest book is Data Integrity and Data Governance: Practical Implementation for Regulated Laboratories was published in 2019 by the Royal Society of Chemistry.
He has contributed to the Records and Data Integrity Guide in 2017 and two Good Practice Guides on Data Integrity Key Concepts and Data Integrity by Design. Bob is also the author of the “Questions of Quality” and “Focus on Quality” columns in LCGC Europe and Spectroscopy magazines, respectively.