Archive for August, 2010

The Case for “Good” Process Maps

Monday, August 30th, 2010

A process map is one of the most fundamental tools for effectively managing and continually improving business processes conducted at a company.  Since we often find life sciences companies lacking adequate maps of important processes (despite detailed SOPs), I thought it would be useful to provide a brief overview of the value of process maps and share some techniques for creating them and making them more effective.

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White House Takes Firm Stand on Pharma Pedigree

Tuesday, August 17th, 2010

The brand integrity/product security world is heating up again, and not just for those focused on Brazil, China, Turkey and the global regulatory landscape.  In June, the US White House released the “2010 Joint Strategic Plan on Intellectual Property Enforcement.” (A report by the IP Enforcement Coordinator, Victoria Espinel) Two key recommendations are: (more…)

Oracle Launches Major Pedigree and Serialization Product

Tuesday, August 17th, 2010

Since we do a lot of pedigree-related work, and deal with many of the vendors in this space, we had an opportunity to get an early look at Oracle’s Pedigree and Serialization Manager (OPSM) solution.  OPSM was designed to create and manage serial numbers, record and transmit serial number hierarchies and create pedigrees.  OPSM was designed to comply with both document model (California) and centralized server (European) methods of pedigree reporting and to be extensible to meet future pedigree formats and data standards.  Additionally, OPSM has an open web services architecture that should allow for additional features, such as product authentication, analytics and enhanced supply chain visibility. 

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Why Cloud Computing Will Penetrate Life Sciences Differently

Monday, August 9th, 2010

More than half of U.S. enterprises now consider cloud computing a viable technology, with favorable views on cloud jumping by more than 50 percent in just a year, according to the Boston market research firm Yankee Group. The information technology-oriented research house said in a report that “cloud computing is on the cusp of broad enterprise adoption.”

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Biopharmaceutical Manufacturing Gaffes in 2010: Why It’s Time To Learn From Failure

Monday, August 2nd, 2010

The ideals of reliability and quality (which I have come to learn is a metaphysical concept) are two distinct topics that have been top of mind lately.  Perhaps it’s due to the fact that as I am getting older, my expectations for dependability have increased dramatically.  Or perhaps it’s the fact that I just left my mechanic in a vapid attempt to solve a car problem that seems to defy all mechanical logic and human comprehension.  So in embracing these two themes, it’s probably high time to evaluate recent manufacturing news and diagnose what is happening, or quite simply, what is not happening. 
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