BioTrax-QMS Print
BioTrax-QMS assists you in all your PET facility's documentation, inventory, and manufacturing needs.  BioTrax-QMS was created out of a need for a more streamlined approach to managing PET manufacturing facilities.  Our software assists with all facets of PET laboratory production and quality documentation, and does so with a user-friendly interface.  With BioTrax-QMS, you have a document repository, inventory tracking, and batch record maintenance system in one complete package.

Included with the software package are standard operating procedures and electronic batch records for the production of some common radiopharmaceuticals.  All process and quality documentation included with the software package can be fully customized to fit the needs of your facility.

The software's improved approach to maintaining laboratory documentation has other advantages.  BioTrax-QMS easily facilitates the record keeping process, which greatly minimizes human error.  Our system utilizes 21 CFR Part 11 compliant electronic signature technology to produce electronic-based audit trails of laboratory production tasks, quality assurance sign-offs, and changes to quality documentation.  Now with automated change control procedures, important data is more readily available to you.

For users, BioTrax-QMS is a quality management system that helps ensure FDA compliant production and manufacturing of PET radiopharmaceuticals.    The BioTrax-QMS software assists in the record keeping of:
  • Facility Tasks
  • Standard Operating Procedure Training
  • Inventory Receipt and Acceptance
  • Equipment Certification and Repair
  • In-process Material Creation
  • Batch Preparation and Quality Control

For administrators, BioTrax-QMS is a quality management system which helps ensure FDA compliant electronic signature and change control standards.  In addition, it is a system that helps configure the areas that assist users in record keeping.  The BioTrax-QMS software assists administrators in managing:
  • Users and Access Levels
  • The Document Repository
  • Facilities and Facility Tasks
  • Employee Training
  • Inventory Components
  • Equipment and Certifications
  • In-process Material Records
  • Batch Records

Call us toll free at 866-791-3673 for more information.