R.D. McDowall

April 01, 2021

“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.

December 01, 2020

The calibration and qualification of analytical systems is a journey, not an event.

November 01, 2020

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.

September 01, 2020

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.

December 01, 2019

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.

November 01, 2019

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.

September 01, 2019

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?

April 01, 2019

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

December 01, 2018

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.

November 01, 2018

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?