Bob McDowall, PhD
Bob is an analytical chemist with over 45 years’ experience including 15 years working in the pharmaceutical industry and over 25 years working for the industry as a consultant. Bob has been involved with specifying laboratory informatics solutions for over 40 years and has nearly 35 years’ experience of computerized system validation in regulated GXP environments.
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Published Content
Total: 15
Article
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.
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.
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.
Article
Data Reporting, Integrity and Compliance
In this article, we examine how analytical scientists can enhance their data sharing and reporting practices, leading to improvements in data integrity and an easier route to compliance within a regulated good manufacturing practice (GMP) environment.
How To Guide
How To Ensure Data Integrity
Download this guide to discover how data integrity is fundamental to quality assurance, process development and production, and analytical development and quality control.
How To Guide
How To Future Proof Your Laboratory Informatics Environment
Download this guide to learn more about laboratory automation strategies, informatics components and key considerations, and process improvement for effective informatics implementation.
How To Guide
Achieving Data Compliance: What Not To Do
Download this guide to learn how to avoid remediations for citations such as loss of electronic records, uncontrolled and unvalidated spreadsheets and conflict of interest.
Article
The Latest Regulatory Guidance for Data Integrity and Regulatory Compliance
Owing to widespread data falsification and poor data management practices, data integrity and compliance with good manufacturing practice (GMP) regulations are currently a major topic in the pharmaceutical industry. To aid our understanding of data integrity concerns, regulatory authorities have issued guidance documents on the topic. This article will give an overview of this guidance and review specific requirements for computerized systems.
Article
Digitization for Data Integrity and Regulatory Compliance
This article will explore how the move to digitize laboratory processes promises to make data integrity and compliance, an essential goal for regulated laboratories, an easier task.
How To Guide
How To Implement a LIMS Successfully
Download this guide to learn about designing and building the LIMS IT platform, interfacing core analytical instruments, training the LIMS project team and LIMS implementation do's and don'ts.
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