Sep 23 2014

BioTrax QMS Installation and Integration

Positron emissions tomography’s (PET) manufacturing sites–large or small, increasingly are looking to integrate the accuracy and efficiency of a technology-based management systems to replace antiquated pen-and-paper batch-record keeping methods. When considering a conversion, administrators are undoubtedly concerned with the degree to which the software installation and training will disrupt daily production and the time it […]
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Apr 16 2014

FDA Inspections: Did You Know?

When the FDA conducts an inspection at your manufacturing facility, will you be ready with the right documentation? In the last couple of years, operators of cyclotrons have been cited for serious deviations from the US Pharmacopoeia (USP) compounding standards and official monograph of Positron Emission Tomography (PET) drugs. Citations can be and are issued […]
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