Mar 31

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 partners of industry to find ec² Software Solutions, a trusted technology provider in the nuclear medicine and molecular imaging fields.

The Solution

For many years ec² Software Solutions has supported Huntsman Cancer Institute’s radiopharmacy with BioRx, a nuclear pharmacy management software, which was designed to manage all aspects of a nuclear pharmacy. After visiting the ec² Software Solutions booth at the SNMMI show each year, representatives from the Huntsman Cancer Institute were able to see the BioTrax QMS software evolve and improve to a point where they were comfortable with making the decision to convert their existing paper based batch records system to a software designed to manage all aspects of their PET manufacturing facility.

In order to meet FDA requirements (21CFR212 & 21CFR11), Huntsman Cancer Institute sought out a QMS software that was regulatory compliant. The goal was to have an electronic system in place to streamline operations and have a centralized repository of all information associated with the facility.

Huntsman Cancer Institute wanted a QMS software that could meet the following requirements:

#1. A dedicated system that manages the workflow of multiple batches and different radiotracers during the day

#2. Inventory tracking with barcodes (full traceability of all raw materials used during production)

#3. Management of SOPs, OOS, Deviations, Equipment Maintenance Records along with a document repository

#4. All-encompassing electronic batch record system with an “All-in-one” approach

#5. An easy to use system that is user friendly

#6. Printing of labels for materials and production batches with accountability

#7. Generating reports for FDA inspections

#8. Secure system with user ID and password protection

#9 .Regulatory (21 CFR 11) compliant software

#10. Training Files for Employees (GMP training / Media-fill / QC training)

The Result

After the installation of BioTrax QMS, Huntsman Cancer Institute is able to generate reports to show the FDA in case of an inspection. All data stored in BioTrax QMS is retrievable through its reporting modules.


About ec² Software Solutions

ec² Software Solutions is an industry leader in the nuclear medicine and molecular imaging fields. The company designs and develops software for every aspect of nuclear medicine, from manufacturing to dispensing to dosing patients. Additional information about ec² Software Solutions is available at

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