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

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.

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.

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.

Understanding Data Governance, Part II

Data governance requires a multi-layered approach that runs throughout a regulated organization from top to bottom.  Although data governance features in the majority of GxP data integrity guidance documents, the approach to the topic should be business-driven rather than regulatory-driven.

Understanding Data Governance, Part I

Raw data is a term that is often used in both good manufacturing practice (GMP) and good laboratory practice (GLP) laboratories but can create confusion and misunderstanding.  What exactly does it mean and what records are within the scope of the term?

What Exactly Are Raw Data?

In April 2016, the FDA issued a draft guidance for industry on data integrity and compliance with cGMP. What does this mean for the laboratory?

What's New with the FDA's Data Integrity Guidance?

Data integrity is currently the hottest topic in regulated laboratories. Understanding what constitutes data integrity and the interactions between the layers is the challenge to ensure that data are accurate, correct and complete. Are you up to the challenge?