The Data Life Cycle
The ISPE Good Practice Guide on Records and Data Integrity defines a data life cycle consisting of: Creation — Processing — Review, Reporting, and Use — Retention and Retrieval — Destruction A robust...
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What do NASA Missions and Pharmaceutical Manufacturing have in common?
NASA recently ended a 20 year 5-Billion-mile space journey as its Cassini space probe burned up in Saturn’s atmosphere (NASA.gov Cassini Mission Site). This $3.26...
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Are You Ready? Major Changes Coming to Europe MDR and IVDR
Introduction: One of the major focuses this year at the RAPs Convergence in DC was implementation timelines for the EU Medical Device Directive and the...
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Spare Parts: The Hidden Cost of Maintaining Equipment
If you own or manage any equipment, you maintain an inventory of spare parts. How have you determined what to keep in your warehouse?...
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From Dragon to Chameleon
Implementing a Serialization Database Across an Entire Enterprise. (more…)
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Maximizing the Impact of Factory Acceptance Testing
Your equipment is ordered. The schedule is set. The team travel plans are made. But are you ready to maximize your experience at the...
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Where to Draw the Line?
What is an appropriate level of GMPs for a supplier manufacturing site? (more…)
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Optimizing Time to Market
In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they are going...
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All Hands Topside for Stores Load
Below are typical pictures of how food and parts are loaded on a submarine prior to deployment. Yes, it is a very manual and...
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