R.D. McDowall

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R.D. McDowall is the director of R.D. McDowall Limited and the editor of the “Questions of Quality” column for LCGC Europe, Spectroscopy’s sister magazine.

Articles

Are You Ready for the Latest Data Integrity Guidance? Part 2: Computerized Systems, Outsourcing, Quality, and Regulatory Oversight

Are You Ready for the Latest Data Integrity Guidance? Part 2: Computerized Systems, Outsourcing, Quality, and Regulatory Oversight

December 1st 2021

We continue our explanation of the new PIC/S data guidance.

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The Humble Instrument Logbook?

December 1st 2017

Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?

What’s New in the New USP ?

What’s New in the New USP ?

September 1st 2017

The new version of United States Pharmacopeia general chapter “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?

Understanding Data Governance, Part II

Understanding Data Governance, Part II

April 1st 2017

Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level.

What's New with the FDA's Data Integrity Guidance?

What's New with the FDA's Data Integrity Guidance?

September 1st 2016

In April 2016, the FDA issued a draft guidance for industry on data integrity and compliance with cGMP. What does this mean for the laboratory?

Understanding the Layers of a Laboratory Data Integrity Model

Understanding the Layers of a Laboratory Data Integrity Model

April 1st 2016

Data integrity is currently the hottest topic in regulated laboratories. Understanding what constitutes data integrity and the interactions between the layers is the challenge to ensure that data are accurate, correct and complete. Are you up to the challenge?