Column: Questions of Quality - Chromatography Online
Column: Questions of Quality
Questions of Quality offers guidance on quality issues relevant to all separation scientists. Method development, data handling, chromatography data systems and laboratory information management systems are covered by leading industry consultant Robert McDowall.

How Much Value Is There in a Software Operational Qualification?

February 1, 2013

Answers to common questions about operational qualification software.

Getting It Write?

November 1, 2012

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?

Fat Finger, Falsification or Fraud?

April 1, 2012

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

How Raw Are Your Data — 2012?

February 1, 2012

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

System Suitability Tests and AIQ (Part 3)

August 1, 2011

A look at the role of system suitability tests (SSTs) during performance qualification (PQ).

Is GMP Annex 11 Europe's Answer to 21 CFR 11?

April 1, 2011

How will the new revision of EU GMP Annex 11 on Computerized Systems and Chapter 4 on Documentation affect chromatographers?

System Suitability Tests and AIQ (Part 2)

December 1, 2010

The concluding part of the series on the role of system suitability tests in the pharmaceutical industry.

Chromatography Standards Certificates

March 1, 2010

There is more to using and interpreting certificates for chromatography standards than meets the eye

Are you Ready for a Strong FDA?

December 1, 2009

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


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