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Maximizing the Impact of Factory Acceptance Testing

September 19, 2017 ||
 
  Your equipment is ordered.  The schedule is set.  The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor?  This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the…

Optimizing Time to Market

June 20, 2017 ||
 
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 to get a drug into trials and eventually to the marketplace as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs),…

All Hands Topside for Stores Load

August 22, 2016 ||
 
  Below are typical pictures of how food and parts are loaded on a submarine prior to deployment.  Yes, it is a very manual and laborious job and often requires crew from multiple departments of the boat.    In civilian industries, it is not quite that difficult to load parts…

20 Years of Meeting a Higher Standard

April 19, 2016 ||
 
Commissioning Agents, Inc. (CAI) was founded with a mission to become the world wide leader of value-added commissioning services for Biopharm facilities and to be an agent for change in the industry.  On the occasion of our 20-year anniversary, we celebrate our past and provide a vision for the next…

Help The OEM Help You. Better Designs From Suppliers With In Depth RFI

April 15, 2016 ||
 
Identifying Original Equipment Manufacturers (OEMs) with the capabilities and experience to design, build and deliver physical assets that perform beyond stakeholders’ expectations is an important initial step in delivering a successful project. Yet when tunnel vision sets in at this early phase of concept and design and firms begin focusing…

Serialization: Are You Ready For Changing Regulations?

April 12, 2016 ||
 
If the pharmaceutical distribution network is at risk, so is patient safety. With counterfeit drugs on the rise, serialization programs are being implemented to safeguard the integrity of product reaching the market. Serialization also provides better controls to communicate recall information should it become necessary.