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Focus on Quality Column

Can You Demonstrate the Integrity of Your Data?

November 1, 2014

Recently, regulators in both the United States and United Kingdom issued guidance concerning laboratory data integrity that followed serious noncompliances found during inspections. Here, we explore what this guidance means for spectroscopy systems used for analysis in regulated laboratories and derive some common-sense guidance that you can follow.

GLP and GMP Approaches to Method Validation — Going the Same Way?

April 1, 2014

A review of the United States Pharmacopeial Convention (USP) stimulus paper on the revision process to adopt quality-by-design principles for the development, validation, and operation of analytical procedures used for good manufacturing practice (GMP) analysis — and how it compares to a draft guidances by the Food and Drug Administration (FDA) for industry on validation of analytical and bioanalytical procedures.

Cloud Computing: How to Choose the Right Cloud Supplier

December 1, 2013

When a laboratory — particularly a regulated GxP laboratory — contemplates using the cloud, finding a suitable supplier is critical

An Integrated Risk Assessment for Analytical Instruments and Computerized Laboratory Systems

November 1, 2013

A risk assessment helps determine the amount of qualification and validation work necessary to show that instruments and computerized laboratory systems are fit for their intended purpose. Here's how to do it.

Why Do We Need Quality Agreements?

September 1, 2013

In pharmaceutical contract manufacturing, the work of analytical scientists is covered by a quality agreement, which is prepared by personnel in the quality control or quality assurance department and focuses on the laboratory analyses provided. But what exactly are quality agreements, why do we need them, who should be involved in writing them, and what should they contain? Here, we answer those questions.

How Complete Are Your Data?

April 1, 2013

A look at what the requirements are for "complete data" for laboratories working under the FDA GMP regulations. We also review the observations listed by inspectors on 483 forms from 2006 to 2012, to assess the common mistakes companies make.

How Much Value is there in a Software Operational Qualification?

December 1, 2012

Answers to common questions about operational qualification (OQ) software

Software Out of the Box?

November 1, 2012

A look at how the term commercial off-the-shelf can be abused in marketing literature.

Is Cloud Computing Right for Your Laboratory . . . or Are You Living in Cloud Cuckoo Land?

April 1, 2012

A discussion of the various options for cloud computing, avoiding the marketing hype and focusing on the potential advantages and disadvantages for your laboratory

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