BioTrax QMS
BioTrax QMS Is Best For:
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 |
|---|
| Server: Rocky Linux 8 (Operating System Installed by ec²) |
| Server: Intel Xeon Series Processor |
| Server: 16GB RAM |
| Server: 1TB Hot Swap Hard Drive (Qty. 2 for RAID 1) |
| Workstation: Windows 10 64 bit |
| Workstation: Intel Core i5 |
| Workstation: 8GB RAM |
| Workstation: 500GB Hard Drive |
| Workstation: Microsoft Word 2016 or Newer |
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:
Pharmacist
Cyclotron Engineer
Administration
Radiochemist
Technician
Production Management
BioTrax QMS Customers
"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."
“I have nothing but good things to say about BioTrax QMS."