R.D. McDowall

R.D. McDowall is principal of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.

Articles

What Is Data Integrity Training?

November 01, 2015

A current hot topic in regulated GXP laboratories is data integrity. Recently, the UK regulator issued an industry guidance on this subject that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?

What's New in the Proposed USP Update?

September 01, 2015

A proposed update to USP on Analytical Instrument Qualification (AIQ) has been issued for public comment. Here, we identify the changes that are proposed and their impact on the AIQ process of analytical instruments and laboratory computerized systems.

How Do You Prepare Reference Standards and Solutions?

April 01, 2015

This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials." This practical guide is worth reading, and its contents should be compared with your current working practices. In addition, we look at options for the preparation of working solutions from stock solutions to see the errors that could occur.

Archiving Electronic Records

December 01, 2007

Paper is easy to archive, but what about archiving electronic records? What do you do with all the electronic records that are generated? In this month's installment, columnist Bob McDowall explores the issue of electronic records management and looks at the recent guidance issued by the OECD for GLP laboratories.