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

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.

Spreadsheets: A Sound Foundation for a Lack of Data Integrity?

When using infrared (IR) instruments in a regulated laboratory, it is essential to conduct meaningful performance qualification (PQ) tests to maintain compliance.

What Does Performance Qualification Mean for Infrared Instruments?

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.

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

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. 

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

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?

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

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

Outsourcing Spectroscopic Analysis?

Regulatory definitions can be confusing at all levels. In this article clear definitions of raw data are clarified and compared. A discussion of static and dynamic data is given along with a detailed summary of the impact of these terms on raw data.

Quo Vadis Raw Data?

The password paradox states that simple passwords are simple to remember but easy to break, but complex passwords that are difficult to hack are also difficult to remember. Is there a better way?

Pesky Passwords?

Does a one size fits all data life cycle meet laboratory requirements for data integrity? No! The reason is that there are many different types of analytical procedures and this requires a flexible analytical data life cycle.

A Flexible Analytical Data Life Cycle?

We live in a new world where users must specify what they want their analytical instruments to do. This discussion will help you figure out how to make sure you get what you need.