Tag: BioTrax QMS

Mar 31 2015

BioTrax QMS Enables Prestigious Cyclotron Facility to Improve FDA Compliance
The Situation The Cyclotron Radiochemistry Lab at Huntsman Cancer Institute is located on the University of Utah Campus in Salt Lake City. A concern about the efficiency of a paper based quality system was the driving force behind their search for an electronic solution. Representatives from Huntsman Cancer Institute turned to industry trade shows and […]
Read More >
Nov 04 2014

Evolve Beyond Paper with BioTrax QMS
The FDA published it’s top 6 major issues for 2013/2014 as PET Inspections major issues in 2013/2014. Note how many of them are about records: Lack of adequate “Out of Specification” investigations Inadequate media fill validations, aseptic techniques and Environmental Monitoring Analytical assay methods not validated or verified for intended use Deficiencies in production and […]
Read More >
Oct 07 2014

FDA Compliance
        Dear Regulatory Affairs, I’ve spent my entire career working in and around FDA regulated medical activities. I know the frustration, anxiety and added expense one experiences preparing for and enduring an FDA inspection. Eight years ago I was overseeing cyclotron operations at a number of different facilities and anticipating that the […]
Read More >
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 […]
Read More >