Tag: QMS

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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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 […]
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Sep 09 2014

How Can BioTrax QMS Help Your PET Facility?
BioTrax QMS™ by ec2 software solutions was conceived by an experienced cyclotron executive to create an electronic means to insure and document that the manufacturing processes under his oversight represented best practices and would withstand FDA scrutiny. Cyclotron facilities invest heavily in the technology needed to produce doses but many operators, ironically, fail to take […]
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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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