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R.D. McDowall
Articles
Are You Ready for the Latest Data Integrity Guidance? Part 1: Scope, Data Governance, and Paper Records
November 01, 2021
In the first article of a two-part series, the new PIC/S guidance is discussed, with particular focus on the scope, data governance, and paper records.
Consigning SneakerNet to the Graveyard of Technology
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.
Are You Ready for a Life Cycle Approach for Analytical Instruments and Systems?
December 01, 2020
The calibration and qualification of analytical systems is a journey, not an event.
Do You Really Understand the Cost of Noncompliance?
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.
Spreadsheets: A Sound Foundation for a Lack of Data Integrity?
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.
Do You Understand the FDA’s Updated Approach to Pre-Approval Inspections?
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.
Data Quality and Data Integrity Are the Same, Right? Wrong!
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.
Analysis of FDA Infrared 483 Citations: Have You a Data Integrity Problem?
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?
Outsourcing Spectroscopic Analysis?
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.
Quo Vadis Raw Data?
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.