Column: Focus on Quality

Apr 01, 2017
Data integrity requires a multilayered approach that runs throughout a regulated organization. Here we discuss the laboratory level, and discuss the impact of the data governance scheme as it cascades down to the processes and systems at the bench. The main focus here is on data ownership and data stewards.
Feb 01, 2017
Data governance to ensure GXP data integrity requires a multilayered approach that runs throughout a regulated organization. Here in Part I of this two-part article, we consider data integrity from the corporate level.
Nov 01, 2016
Raw data is a term that is often used in both good manufacturing practice and good laboratory practice, but there is often confusion surrounding the term. What exactly does raw data mean and what records are within the scope of the term?
Sep 01, 2016
Data integrity is the currently hottest topic in regulated good practice (GxP) laboratories. Here’s what you need to know about the latest guidelines, issued by the FDA in April 2016.
Apr 01, 2016
Thinking about data integrity in four layers makes it easier to fully understand the overall scope and complexity of this topic. It also facilitates proper implementation of data integrity programs to ensure effective regulatory compliance.
Dec 01, 2015
The United States Food and Drug Administration has issued a draft guidance on the development and submission of near infrared (NIR) analytical procedures. Here, we explain and critique key aspects of the document.
Nov 01, 2015
The UK regulatory body issued a guidance that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?
Sep 01, 2015
Changes have been proposed to the United States Pharmacopeia Chapter <1058> on analytical instrument qualification. Here is what you need to know about the impact of those changes on the qualification of analytical instruments and laboratory computerized systems.
Apr 01, 2015
This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials.
Dec 01, 2014
Special Issues
The European regulations on good manufacturing practices (GMPs) — Annex 11 — are having a strong influence on good laboratory practice (GLP) and good clinical practice (GCP).
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