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

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.

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?

Before a CDS can be considered capable for use in a regulated laboratory, it must meet a number of requirements.

A question that keeps raising its head when working in a regulated laboratory is can chromatographers integrate peaks manually? If they can, when can they do it? Also if they can manually integrate, when should they not do it?

Chromatography data systems (CDSs) have had a starring role in many regulatory citations involving falsification and fraud in analytical laboratories regulated by Good Manufacturing Practices (GMP). In this instalment of "Questions of Quality" we will examine the citations and identify the technical and procedural controls required to ensure data integrity within these systems. Although focused primarily on the pharmaceutical industry, the principles described here are applicable to all laboratories working to established quality standards.

A recent stimulus to the review process article by the United States Pharmacopoeia (USP) Expert Committee is proposing a major change in the way regulated laboratories develop, validate and control analytical procedures. Is this Quality by Design (QbD) for the chromatography laboratory?

The concluding part of the article from last month's "Question of Quality" on what "complete data" actually means in practice.

This article will explore what is meant by "complete data" in the context of a chromatography data system and, with an analysis of FDA 483 citations, explore the problems when a laboratory fails to understand this phrase.

Answers to common questions about operational qualification software.

Answers to common questions about operational qualification software.

Written procedures used by trained staff are the basis for all quality systems but there are many ways of writing a procedure. Are you getting it write?

The new version of EU GMP Annex 11 has been effective for about a year. There are new technical requirements in the Annex – do your laboratory computerized systems comply with them all? In this column we look at the impact of these new regulatory requirements for Good Manufacturing Practice laboratories.

Mistakes or fat finger moments are part of human nature but where is the dividing line between this and falsification and fraud?