July 2013

For Blood & Biologics Companies

Report Highlights Need to Address Root Cause of R&D

by: Cindy Fazzi, MasterControl Inc.

Pharmaceutical and biotechnology companies need to address the root cause of their drug development inefficiencies. Most companies focus their efforts on “enhanced clinical trial designs” that use biomarkers and adopt advanced statistical analyses, but they still need to hone their efforts at streamlining their drug development process, according to a recent report by the Tufts Center for the Study of Drug Development.

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Correcting and Detecting CAPA Horrors

by Peter Knauer, MasterControl Inc.

The long history of Corrective and Preventive Action (CAPA) requirements within the Food and Drug Administration's (FDA) Quality System Regulations---and specifically 21 CRF 820.100 and ICH Q10---implies that most biomedical companies have evolved a certain level of mature thinking and a good understanding of the fundamental requirements for CAPA systems. This, unfortunately, is not always the case. I am currently spending a lot of time working with client companies in remediation mode; that is, after FDA has found enough flaws to issue a 483 or warning letter. I would like to point out some common CAPA problems that can be proactively rectified to avoid citations in the first place.

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Business Benefits of Archiving

by: Jim Cook, Arkivum

The word “archive” is springing up all over the world of IT and data management. Why now, and what are the implications to an organization working within the highly regulated world of a GxP environment? This article sets out some of the key business drivers around long-term data storage, and offers some lifelines to IT professionals drowning under a deluge of data.

In a recent report , McKinsey projects a 40% growth in global data generated per year, while growth in global IT spending will manage only 5% each year. Against that backdrop McKinsey believes that the value of making use of big data to the U.S. healthcare market could be $300 billion, more than double the total annual healthcare spending in Spain.

So we know that data growth is enormous, that IT budgets will be hard pushed to cope, and yet there are huge benefits to those that are able to successfully ride this roller coaster.

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