spacer
home > ebr > winter 2018 > utmost integrity
PUBLICATIONS
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.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
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.

spacer
Darren Barrington-Light
spacer
spacer
spacer
Brian Alliston
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Porton Biopharma opens new facility to make more of its childhood cancer cure

In a ribbon cutting ceremony, John Glen MP for Salisbury and South Wiltshire today (27th April 2018) officially opened Porton Biopharma Limited’s (PBL) new fermentation facility which will be used to manufacture the company’s life-saving leukaemia drug Erwinase®.   
More info >>

White Papers

Tightening Your Supply Chain Against Counterfeits

World Courier

As today’s global pharmaceutical supply chain grows increasingly longer and more complex, each link provides added opportunity for counterfeiters. While pending regulatory changes promise to tighten the supply chain with respect to production and distribution entities and new packaging technologies will make the identification of counterfeit products easier, the logistics of global distribution remains a weak link. How can the pharmaceutical shipper ensure the security of the supply chain over thousands of miles and extended periods of time when the product is no longer in his possession?
More info >>

 
Industry Events

On Helix 2018

10-11 July 2018, The Cambridge Building, Babraham Research Campus

ON Helix is a two-day event aimed at informing delegates of how to turn early stage inventions and ideas into innovative health treatments (new medicines, novel biomarkers, useful medical devices or improved medical practices).
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement