Topic

R.C. McDowall is the principle of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.

Articles

In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.

Are You Ready for the Latest Data Integrity Guidance? Part 1: Scope, Data Governance, and Paper Records

R.D. McDowall is principal of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for 

Computerized system validation (CSV) has an uninspiring reputation for
being a slow, no-value-added activity that only wastes time and delays the
implementation of new software. Is that an accurate portrayal? And is it a
necessary evil?

Does CSA Mean  “Complete Stupidity Assured?”

“SneakerNet,” or the manual transfer of data using a disk or USB stick from one computer system to another, should be long dead, but this noncompliant transfer process still survives.

Consigning SneakerNet to the Graveyard of Technology

Sampling and Analytical Record

Chromatography Data System

The calibration and qualification of analytical systems is a journey, not an event.

Are You Ready for a Life Cycle Approach for Analytical Instruments and Systems?

Two recent warning letters show that the US FDA is substantially increasing the amount of remediation work it requires for companies to correct data integrity noncompliance. That work can be very expensive—far exceeding the cost of ensuring compliance in the first place.

Do You Really Understand the Cost of Noncompliance?

The California Department of Public Health has proposed to establish the first regulatory limit in the United States for hexavalent chromium (chromium-6) in drinking water. The proposed Maximum Contaminant Level (MCL) sets the limit for hexavalent chromium at 10 parts per billion. California, like those of other states and United States federal government, currently only regulates total chromium levels.

First Regulatory Limit for Hexavalent Chromium in Drinking Water Awaited in California

This article covers the changes so far to United States Pharmacopeia (USP) chapters <232> and <233>, the International Conference on Harmonisation (ICH), the European Medicines Agency (EMA), and the European Pharmacopoeia (EP), impending changes, and options for preparing for those changes.

What's New in Testing Pharmaceuticals for Metals: Metals and Limits in Limbo

In this column, Bob McDowall discusses the impact of USP general chapter 1058 on the spectroscopy laboratory.

Regulatory Standards/GLP/GMP Compliance