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Consumers Must Drive Quality Health Care
William L. Roper
A revolution is working its way through America’s health care systems. Like many great revolutions, it’s about empowerment and the creation of a new paradigm. It won’t happen overnight, but the forces at work are irresistible and will bring new hope and new responsibilities. The agent…
Quality Assessment: Process or Outcome?
Tim Postema
The Dutch public health care system is being transformed in various ways. With an increasing focus on efficiency and consumer driven care, health institutions in The Netherlands are forced to critically evaluate their actions and processes. With recent political developments creating a more liberal…
RFID in Health Care: a Four-Dimensional Supply Chain
Marlo Brooke
The groundswell of radio frequency identification devices (RFID) in health care may be clouded by the stomping of Wal-Mart, but the biotechnology and pharmaceutical industries are quietly becoming one of the top innovators and users of RFID, and they’ll likely outpace other market segments in the…
How Experimental Design Optimizes Assay Automation
Optimizing biological assay conditions is a demanding process that scientists face every day. The requirement is to develop high-quality, robust assays that work across a wide range of biological conditions. The demand is to do this within a short development time frame. To overcome these obstacles…
New Biopharmaceutical Coalition Aims to Support SAFE Initiative
Laura Smith
In hopes of cutting administrative costs and streamlining the amount of time it takes to get new drugs to consumers, eight global pharmaceutical manufacturers have formed a coalition, SAFE-BioPharma, to support the widespread adoption of the new global digital identity standard, Secure Access for…
A Blueprint for Electronic Record Retention
Tamar June
Companies struggling to comply with the FDA’s myriad electronic recordkeeping regulations should take a deep breath and follow it up with a long, careful look at the FDA’s actual GxP and 21 CFR Part 11 rules. After a careful reading of the admittedly long and sometimes dry rules, it should become…
The Business Case for FDA CFR 21 Part 11 Compliance
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Medical Matters
BSI
More than a decade ago, Osteoimplant Technology Inc. provided the orthopedic prosthesis for a complete hip replacement for Mikhail Lavrovsky, one of the most famous lead dancers with the Bolshoi Ballet. He was able to dance with the replacement and continued to make appearances around the world.…
The Business Case for FDA CFR 21 Part 11 Compliance
Tamar June
If you are thinking of CFR 21 Part 11 compliance in terms of what the FDA may or may not require, you are missing a huge opportunity to make your business more efficient, nimble and ultimately profitable by improving the quality of your operation and its products. That’s the consensus of dozens of…
Coming Soon
Quality Digest
Our BioMed Community is under Construction. Check back soon. Our launch date will be Jan. 26, 2005

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