In the world of data integrity, the focus is typically on the data and the numbers. How can technology, such as a laboratory information management system (LIMS), help to ensure data integrity?

Data integrity issues are changing the way that we should be undertaking computerized system validation (CSV) of our chromatography data systems (CDSs). Do you understand what is required in the brave new world of CSV?

A future CDS should be able to handle five key functions that currently are performed manually.

The United States Food and Drug Administration has issued a draft guidance on the development and submission of near infrared (NIR) analytical procedures.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.

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?

Primary record is a term that was defined by the MHRA (Medicines and Healthcare products Regulatory Agency, the UK drug regulator) in data integrity guidance issued in 2015. In this instalment of Questions of Quality we explore what this term means in practice, and compare it with raw data in the European Union Good Manufacturing Practices (EU GMPs) and complete data in US Food and Drug Administration (FDA) GMPs. Why can’t we have harmonization of terms?

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.

What’s in a Name?

What’s in a Name?

Before we can define an ideal CDS, we must first consider its role.

This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials.

This instalment of “Questions of Quality” looks at problems with an operational liquid chromatograph to see if they can be picked up in the performance qualification (PQ) or prevented in the operational qualification (OQ).

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).

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).