R.D. McDowall

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.

Answers to common questions about operational qualification software.

Answers to common questions about operational qualification software.

Written procedures used by trained staff are the basis for all quality systems but there are many ways of writing a procedure. Are you getting it write?

The new version of EU GMP Annex 11 has been effective for about a year. There are new technical requirements in the Annex – do your laboratory computerized systems comply with them all? In this column we look at the impact of these new regulatory requirements for Good Manufacturing Practice laboratories.

Mistakes or fat finger moments are part of human nature but where is the dividing line between this and falsification and fraud?

The results of a recent survery on stationary phases used in high performance liquid chromatography (HPLC) are revealed.

Can you qualify or calibrate your chromatograph using a system suitability test? No. However, for the doubters among you I'll spend the rest of this two-part article series explaining why.

Can you qualify or calibrate your chromatograph using a system suitability test? No. However, for the doubters out there this column will explain why.

There is a new FDA Commissioner who wants a "strong FDA". Chromatographers must be prepared to be compliant and remain compliant — or else!