Pharmaceutical Data Integrity: Are Your Controls Tough Enough?

Blog   Aug 25, 2017 | By Darren Barrington-Light, Senior Manager Product Marketing, Informatics & Chromatography Software, Thermo Fisher Scientific

Pharmaceutical Data Integrity: Are Your Controls Tough Enough?
 
 
 
 

Comments | 1 ADD COMMENT

Sanjivanjit Bhal | Sep 28, 2017

This is an interesting topic. The FDA recommendation identifies the main problems to be unreliable tracking/reporting of particles in material (visual inspection), shredded HPLC chromatograms, and out-of-spec (OOS) forms. A CDS system will limit the impact of shredded chromatograms. But systems, such as ACD/Spectrus Platform that handle multiple types of laboratory data and results can help with the data integrity concern. These systems might even be better because they can store text, images, as well as data and metadata from a variety of instruments including Chromeleon chromatographic data with some method information.


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