Nov 04

Evolve Beyond Paper with BioTrax QMS

The FDA published it’s top 6 major issues for 2013/2014 as PET Inspections major issues in 2013/2014. Note how many of them are about records:

  1. Lack of adequate “Out of Specification” investigations
  2. Inadequate media fill validations, aseptic techniques and Environmental Monitoring
  3. Analytical assay methods not validated or verified for intended use
  4. Deficiencies in production and process controls
  5. Lack of QA oversight for batch releases
  6. Lack of appropriate training records

BioTrax Quality Management System helps your cyclotron facility to evolve beyond paper, and to meet regulatory requirements, while efficiently managing inventory, manufacturing and training. In FDA inspections, FDA is looking for your facility to accurately identify production yields, failures during QC testing, as well as reasons for and quantities of deviations or non-conformances. Do you have the ability to generate the reports that will document your compliance?

BioTrax QMS combines the benefits of an electronic inventory tracking system with a batch record production system, providing you with a streamlined and paperless approach to managing your PET facility’s cGMP needs. The system features:

  • All-encompassing electronic batch record system with an “all-in-one” approach
  • Full traceability of all raw materials used during production, via Inventory tracking with barcodes, and printing of labels for materials and production batches with accountability.
  • User friendly interface provides one-click shortcuts to quickly access daily laboratory tasks
  • Document repository that provides easy access to and control of facility documents such as SOPs.

Is your goal to have an electronic system in place to streamline operations and have a centralized repository of all information associated with the facility? BioTrax QMS minimizes human error, promotes compliance, improves quality and reduces costs. BioTrax QMS offers a better way to manage both your facility and reporting, making compliance infractions or production delays a thing of the past.
To learn more about BioTrax QMS, visit online to schedule a conference and detailed presentation.


If you want to meet regulatory requirements for your cyclotron facility while efficiently managing your inventory, manufacturing and training, it’s time to evolve beyond paper. Trying to meet FDA reporting needs using outdated manual systems can quickly leave you buried under a mountain of paperwork. The FDA wants data that identifies exactly what your production yields were, how many failures occurred during QC testing, if they were deviations or non-conformances and why.

And in today’s market you simply can’t afford compliance infractions or production delays. Now there’s a better way to manage both your facility and your reporting.

Introducing BioTrax QMS by ec2 Software Solutions. BioTrax QMS gives you a paperless way to manage every aspect of your manufacturing facility. It integrates a central document repository with raw material tracking, production, training, equipment, and facilities management into a single automated solution. Customizable design allows you to have all of your manufacturing documentation in one format with a user-friendly interface. The electronic repository stores all SOPs, training materials, spec sheets, and other documents in one location.

This gives you complete control over every document with a clear record of all changes and revisions along with electronic signatures. It also allows you to create batch records that connect all data-related documents with a full audit trail. And you can manage inventory by generating barcodes that label materials is accepted, rejected or quarantined for internal tracking cradle-to-grave

Electronic worksheets walk users through each manufacturing step in quality-control procedure. This ensures they always capture the right information as it happens. You can require staff to complete training before they’re allowed to do tasks. You could also create specific exams with minimal passing scores. Best of all, compliance reporting is this simple as a few mouse clicks which means now you can quickly and affordably improve efficiency, reduce costs and end the paper-chase forever with BioTrax QMS quality management at your fingertips.

BioTrax QMS offers the best value for any automated solution of its kind. Contact us to schedule a detailed presentation on all the ways you can improve quality of streamlining your manufacturing operations, and you can always call with questions or request a proposal.