Author | R.D. McDowall

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

Do You Understand the FDA’s Updated Approach to Pre-Approval Inspections?

December 01, 2019

Spectroscopy

Article

The Food and Drug Administration (FDA) has issued an updated version of its Compliance Policy Guide for Pre-Approval Inspections (PAI). This article will guide you on this policy’s impact on analytical procedures and data included within regulatory submissions.

Data Quality and Data Integrity Are the Same, Right? Wrong!

November 01, 2019

Spectroscopy

Article

Data integrity has been the subject of many “Focus on Quality” columns over the past few years (1–5). However, we have never mentioned, let alone discussed, data quality.

Analysis of FDA Infrared 483 Citations: Have You a Data Integrity Problem?

September 01, 2019

Spectroscopy

Article

Analysis of FDA Form 483 observations and warning letters for infrared spectrometers reveals a range of data integrity problems and a lack of laboratory procedures for the technique. Is your laboratory in the same situation?

Outsourcing Spectroscopic Analysis?

April 01, 2019

Spectroscopy

Article

In the current data-integrity–centric world, is outsourcing your spectroscopy work a good idea? To answer this question, one must consider several factors.