Tag: pharmacy compliance

Mar 03 2016

How To Dispose of Nuclear Pharmaceuticals
Federal regulations require hospitals and outpatient facilities to keep a record of the distribution of radiopharmaceuticals. They are required to track dosage amounts and radiation readings. When theses facilities need to dispose of the radiopharmaceutical inventory, they send the containers back to the manufacturer and report this to the FDA. The steps taken can be […]
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Sep 16 2014

Users Questions Answered – How to Set Up A Backup
Data loss can occur in any number of ways including human error, computer virus, hardware or system failure, power outage or other. The remedy is to have a data back-up plan in place, to ensure data is adequately protected and can be recovered in a timely manner.  With our clients data protection in mind, we […]
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Jul 01 2014

New FDA Drug Quality Regulations Require Detail Reporting
Recent news has custom-drug makers under public and government scrutiny.  The US Food and Drug Administration has citied drug makers for not meeting new regulations passed by President Barack Obama when he enacted the federal Drug Quality and Security Act in November of 2013.  This new act is designed to rein in larger drug facilities […]
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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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Apr 03 2014

BioTrax QMS Software For Your Facility
The BioTrax QMS software facilitates regulatory compliance, increases efficiencies, improves quality and reduces operational costs.  To be able to accomplish this BioTrax QMS integrates the programs document repository, raw materials, production, equipment, training and facilities modules into a single comprehensive package.  The integration of these modules allows the production staff, quality staff and management to […]
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