BioTrax QMS

BioTrax QMS Is Best For:

Inventory Tracking PET Quality Management

BioTrax QMS combines the benefits of an electronic inventory tracking system with a batch record maintenance system, providing you with a streamlined and paperless approach to managing your PET facility’s Current Good Manufacturing Practice (CGMP) regulation needs. This program minimizes human error, ensures compliance, improves quality, and reduces costs. BioTrax QMS integrates central document repository, raw material tracking, production, training, equipment, and facilities management into a single automated solution.

FDA Compliant

Easily Comply With Current Regulations

BioTrax QMS facilitates compliance with federal reporting regulations including: 21 CFR Part 11, 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 212, and USP 823, all at the click of a button!

Electronic Repository

Store All Your Documents Digitally

BioTrax QMS stores all SOPs, training materials, spec sheets and other documents in one location, and keeps a record of all changes, updates and electronic signatures.

Inventory Management

Management at Your Fingertips

The software streamlines inventory management by generating and printing barcodes, tracking the use and disposal of raw materials, and monitoring the receipt of materials.

Batch Record Management

Keep Your Batch Records Connected

BioTrax allows you to create batch records and connect them all digitally, so you can access all of your important information from one convenient location.

Training Management

Manage Your Employee Training Program

Ensure required employee training, establish exams with a minimum passing score requirement, associate current training media with exams, and require administrator review and approval of exams taken.

Equipment Management

Manage Equipment Certifications

Force certifications to be completed for specific tasks and designate appropriate frequencies for recertification. Users can also associate groups to equipment and track equipment repair.

System Messages

All Messages in One Location

Set and view reminders for sterilities, document sign-offs, training needs, equipment certifications, and facility tasks. You can also view tasks due by a designated time in the future, or sort tasks into easily maneuverable sections.

System Requirements
Windows 7 64-bit or above/Linux for server
Intel Core i5
4GB RAM
250GB HDD
20” display
Laserjet Printer
Dymo Label Printer

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Interface Options Available for This Product:

  • While there are no interface options currently available, we are always working to improve our interface design based on feedback from our current clients. Check back for updates!

Who Does BioTrax QMS Help?

BioTrax QMS was created to provide your facility with an easily accessible, comprehensive database and an efficient system for inventory tracking and batch record maintenance. If you are one of these people, BioTrax QMS will make your life easier:

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Pharmacist

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Cyclotron Engineer

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Administration

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Radiochemist

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Technician

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Production Management


BioTrax QMS Customers

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"The inventory capabilities (raw material check-in, IPM batches, etc.) of BioTraxQMS are superb, and allow for a seamless incorporation into the respective batch records."

Hendrik, QA, Precision Nuclear
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“I have nothing but good things to say about BioTrax QMS."

NCM USA

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ec2 Software Solutions provides innovative products that simplify workflows and reduce errors to create streamlined operational processes in your facility. Experience the benefits today!