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?

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?

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?