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European Biopharmaceutical Review

Utmost Integrity

EBR:Why is data integrity so important to the biopharmaceutical industry?

Darren Barrington-Light: The importance of data integrity is nothing new: the accuracy, consistency and completeness of biopharma data has long been of interest to regulatory bodies. However, as international outsourcing becomes increasingly commonplace and supply chains grow in complexity, regulatory authorities are raising their expectations when it comes to the integrity of this data. We have seen from a number of highprofile cases that practices that might once have passed are now inadequate from a regulatory standpoint.

Brian Alliston: At the end of the day, the products we produce must be effective and safe to use. All of us in the biopharma industry have a responsibility to patients to be up to date with the latest data integrity requirements.

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Darren Barrington-Light is a Senior Manager Product Marketing at Thermo Fisher Scientific, with over 23 years’ experience in the fields of analytical chemistry, chromatography hardware and computer software. After working with Chromeleon CDS for nearly 13 years, he joined the Chromeleon CDS product management team seven years ago, where he has been involved in all aspects of the software’s development.

Brian Alliston is a Data Integrity Expert and CDS Specialist at Sterling Pharma Solutions, where he heads the Chromeleon administration team. He supports quality control and development analysts in the use of Chromeleon CDS and oversees the development of training procedures, SOPs and product-specific report templates.

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Darren Barrington-Light
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Brian Alliston
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