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R.D. McDowall | Authors
Articles
Are You Invalidating Out-of-Specification (OOS) Results into Compliance?
Are your OOS investigations scientifically sound and is the assignable cause correct? Or are OOS results invalidated using the ever-popular justification of analyst error?
What’s New in the New USP ?
The United States Pharmacopeia general chapter on Analytical Instrument Qualification has been updated and became effective 1 August 2017. So, what has changed?
Data Integrity Metrics for Chromatography
The authors discuss metrics for monitoring data integrity within a chromatography laboratory, from the regulatory requirements to practical implementation.
The Ideal Chromatography Data System for a Regulated Laboratory, Part IV: Assuring Regulatory Compliance
The first three articles in this series discussed where and how a CDS fits into a regulated laboratory, the overall requirements for the architecture of a future system, and additional items to enable effective electronic ways of working. The final part of this series looks at regulatory compliance of a future system as well as a summary of the 15 recommendations made in this series.