R.D. McDowall | Authors

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


Are Spreadsheets a Fast Track to Regulatory Non-Compliance?

This article uses case studies to explore the use and misuse of spreadsheet calculations in conjunction with a chromatography datasystem (CDS) in regulated GXP laboratories. What wonders of non-compliance will we find? How and when should spreadsheets be used in chromatographic analysis?

Understanding the Lifecycle Approach for Analytical Procedures

A key component for data integrity is having accurate and precise analytical procedures that are validated for intended use. Changes in the way that procedures are specified, developed, validated, and operated are coming. Here is what you need to know.

Can We Continue to Draw the Line?

Chromatographic peak integration continues to be a major regulatory issue and was first discussed in this column in 2015. Is the approach to manual intervention and manual integration outlined still acceptable in the light of regulatory citations and guidance documents published since then?