Category: Quality Management

May 26 2015

FDA INSPECTION RESULTS – PET DRUG FACILITIES 2013-2014
When keeping your facility compliant and ready for an FDA audit, its important to have as much information as possible. Below is a list of 2013-2014’s FDA PET Facility audit results. TOP 6 Major Issues Lack of adequate out of specification (OOS) investigations Inadequate media fill validations, aseptic techniques and environmental monitoring Analytical assay methods […]
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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 […]
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Dec 23 2014

Cybersecurity and Managing your Information Online
There are more reasons than ever to think about your online safety: in addition to cyber-thievery, hacking and identity theft, a growing number of information is gathered via social media. And the concern is not only for the general public and consumers, it also extends to corporate HQs and into the healthcare industry. Recently, the FDA […]
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Nov 12 2014

Maintaining Good Manufacturing Practices
It is important that manufacturers of isotopes and radiopharmaceuticals maintain consistent high quality when supplying pharmacies and PET centers. It is critical that the products provided by the nuclear medicine industry allow for safe and effective imaging and treatment of disease. Toward this end, good manufacturing practices have long been promoted by the FDA to […]
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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 […]
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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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