Bob McDowall

Paper, Paper Everywhere but None of it Controlled?

LCGC Europe - Sep 01, 2016

One of the common threads in the six data integrity guidance documents published to date is the need to control any blank forms used in regulated GXP laboratories. This month’s “Questions of Quality” is focused on how to interpret the regulator’s requirements for this topic. We also pose the question: Is paper the best way to record regulated data?

How Important is Data Integrity to Regulatory Bodies?

Pharmaceutical Technology - Mar 02, 2016

Data integrity is a widespread, global problem that must be addressed.

How Important is Data Integrity to Regulatory Bodies?

BioPharm International - Mar 01, 2016

Data integrity is a widespread, global problem that must be addressed.

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

LCGC Europe - Apr 01, 2011

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

Why System Suitability Tests Are Not A Substitute for Analytical Instrument Qualification or Calibration (Part 2)

LCGC Europe - Dec 01, 2010

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

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