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

Articles

It is traceability that shows that the ALCOA criteria does not exist in individual silos, but that they all interact with and are dependent upon each other.

Is Traceability the Glue for ALCOA, ALCOA+, or ALCOA++?

We continue our explanation of the new PIC/S data guidance.

Are You Ready for the Latest Data Integrity Guidance? Part 2: Computerized Systems, Outsourcing, Quality, and Regulatory Oversight

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.

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

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.

Regulatory Standards/GLP/GMP Compliance