Chris Burgess, PhD, is an analytical scientist at Burgess Analytical Consultancy Limited, ‘Rose Rae,’ The Lendings, Startforth, Barnard Castle, Co Durham, DL12 9AB, UK; Tel: +44 1833 637 446;
[email protected]; www.burgessconsultancy.co
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?
Pharmaceutical Technology - Feb 02, 2016
Performing a measurement uncertainty calculation is often seen as problematic.
LCGC North America - Feb 01, 2016
The final part of this series looks at the regulatory compliance of a future system and provides a summary of the 15 recommendations.
LCGC Europe - Aug 12, 2015
What’s in a Name?
LCGC Europe - Aug 12, 2015
What’s in a Name?
LCGC North America - Aug 01, 2015
Before we can define an ideal CDS, we must first consider its role.
Pharmaceutical Technology - Oct 02, 2014
Calculate a risk-based guard band associated with reportable values derived from knowledge of the analytical procedure capability.
Pharmaceutical Technology - Jun 02, 2014
Statistical analysis shows how much testing is needed to deliver a reliable estimate result.
Pharmaceutical Technology - Jan 02, 2014
This article takes a statistical look at the calibration requirements for a UV spectrometer.
Pharmaceutical Technology - Sep 02, 2013
How good is a reportable value?
Pharmaceutical Technology - Jul 02, 2013
The author discusses the purpose of analysis and testing and the implications for specifications and their underlying statistical distribution.
Pharmaceutical Technology - Apr 02, 2013
The mysteries of rounding are exposed; strict, unbiased rounding can be applied.
Pharmaceutical Technology - Feb 02, 2013
Two methods to evaluate retest data following out-of-specification results.
