Column: Focus on Quality

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

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++?

Computerized system validation (CSV) in good practice (GxP)-regulated laboratories is alleged to take ages and generate piles of paper to keep inspectors and auditors quiet. To the rescue is the draft FDA guidance on computer software assurance (CSA). But...is this really the case?

CSA: Much Ado About Nothing?

 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.

Consigning SneakerNet to the Graveyard of Technology

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?

Spreadsheets are often used to perform GMP-related calculations, but can lead to serious problems and unnecessary risk. We explain why the use of spreadsheets is heavily discouraged in a regulated laboratory environment.