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A greyscale headshot of Bob McDowall

Bob McDowall, PhD profile page

Director

 at R D McDowall Limited


Bob is an analytical chemist with over 50 years’ experience, including 15 years working in the pharmaceutical industry and over 30 years working for the industry as a consultant. Bob has been involved with process redesign, specifying and implementing laboratory informatics solutions for over 40 years and has nearly 35 years’ experience of computerized system validation in regulated GXP environments. Bob is also a trained auditor. He has run training courses on computerized system validation, digitalization, LIMS, instrument qualification, data integrity and auditing since 1988.


Education


London Hospital Medical College  


Awards & Certifications


1997 LIMS Award from the LIMS Institute (Pittsburgh, USA)


Accreditations


Fellow of Royal Society of Chemistry (FRSC) recognised by Royal Society of Chemistry

Chartered Chemist (CChem)

Chartered Scientist (CSci)


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Content Written By, Reviewed By, or Featuring Bob McDowall, PhD
Total: 23
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How To Guide

Top Tips for Designing and Implementing a Custom LIMS

Standard LIMS platforms don’t always match how a lab truly operates. This guide highlights the key considerations for building a custom LIMS, including how to justify the investment and manage long-term success.
Ladder resting upon a stack of blue and green books with a lightbulb at the top, representing data literacy.
Article

Data Literacy: The Foundation of Quality Management Maturity?

Is your organization data literate? This article explores what data literacy is and its impact on an organization’s trajectory towards ICH Q10 and QMM.
Frustrated scientist holding a laptop over his head in a laboratory.
Article

Draft Annex 11 Revision: From Interpretive to Prescriptive Regulation

This article provides detailed analyses of Annex 11 revision and the applicable clauses of Chapter 4 that impact computerized systems.
Person typing on a laptop with digital icons representing data analysis and audit trail processes.
Article

Audit Trail Requirements for a Digitalized Regulated Laboratory

This article discusses options for reviews, the regulatory requirements and guidance for audit trails, audit trail design, procedures for audit trail review and explains how to apply ALCOA++ principles for effective review of entries.
Vintage Apple Macintosh computer set among ornate wooden furniture, representing the Museum of Analytical Antiquities.
Article

The Museum of Analytical Antiquities

This article suggests ways to keep your analytical systems current and compliant and explores why this is so important.
Article

Computer Software Assurance: Perfect Solution or Confidence Trick?

This article takes an analytical approach to the various CSA claims to determine if CSA used in regulated pharmaceutical laboratories can be the perfect solution or is a confidence trick.
Symbols relating to compliance on a blue background
How To Guide

Top Ten Tips for Data Compliance

Data compliance is everybody’s job, a fact that must be reinforced by management throughout the organization. Download this guide to explore ten top tips to achieve data compliance.
Various icons relating to data floating in front of a keyboard
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Data Reporting: Connecting the Islands of Automation

In this article, we explore ways analytical scientists can improve their data reporting and sharing practices, leading to improvements in data integrity and regulatory compliance.
Data Integrity Risks
How To Guide

How To Reduce Data Integrity Risk

The aim of this guide is to provide practical advice on how to reduce data integrity risk and ensure GxP compliance. Learn from those in the industry who have failed to comply with data integrity regulations and who have been on the receiving end of an FDA inspection.
A system notification with the words "Software update required." and an "Update Now" button.
How To Guide

How To Future-Proof Your LIMS: Handling Software Updates

Download this guide to explore types of LIMS upgrades, on-premises installation and SaaS installation.
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