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

The publication of a new FDA compliance policy for pre-approval inspections (PAIs) introduces a new objective to inspect research and development in 
pharmaceutical development. We explore how this could influence the PAI process now.

Guess Who’s Coming  to Inspect R&D?

Now that the draft FDA guidance on computer software assurance (CSA) is out, we can see what it is—and is not.

CSA: Much Ado About Nothing?

A look at two ICH draft publications reveals that the EWG has much revision work to do for these publications to fully cover the validation lifecycle process.

Quo Vadis Analytical Procedure Development and Validation?

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

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++?

 is the director of R.D. McDowall Limited and the editor of the “Questions of Quality” column for 

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

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.

Regulatory Standards/GLP/GMP Compliance