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R.D. McDowall | Authors
Articles
How Static Are Static Data?
A balance printout is a fixed record, and is also called static data. But how static are static data when the weight is used in a chromatographic analysis? Also, have some regulatory data integrity guidance documents failed to comply with their own regulations?
It’s Qualification, But Not As We Know It?
Qualification and calibration of high performance liquid chromatography (HPLC) chromatographs is a regulatory requirement, but how proscriptive should guidance be?
The Hidden Factory in Your Laboratory?
There is a hidden factory in plain sight in many laboratories. Not many people know of its existence, yet it stares back at you when you work. What is the output from this hidden factory? Paper.
What’s Good About the WHO Good Chromatography Practices Guidance? Part 2
In September, the World Health Organization (WHO) issued a new guidance document on Good Chromatography Practices. What guidance does it contain and is it useful? Has the document failed its system suitability test (SST) acceptance criteria?
What’s Good About the WHO Good Chromatography Practices Guidance? Part 1
In September the World Health Organisation (WHO) issued a new guidance document on Good Chromatography Practices. What guidance does it contain and is it useful? Has the document failed its SST acceptance criteria?
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?