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

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.

What! I Have to Specify My Spectrometer?

Good practice (GxP) regulations require an instrument maintenance and use log. Have spectroscopy laboratories and software suppliers emerged from the Middle Ages yet?


The Humble Instrument Logbook?

It has been 20 years since 21 CFR 11 came into effect. And with increased emphasis on data integrity, an audit trail is essential for spectroscopy software. Why then do many audit trails fail to meet regulatory requirements?

Why Is My Application’s Audit Trail Rubbish?

The new version of United States Pharmacopeia general chapter  “Analytical Instrument Qualification” became effective August 1, 2017. What does this mean for you?

What’s New in the New USP ?

Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level.