BioTrax QMS™ by ec2 software solutions was conceived by an experienced cyclotron executive to create an electronic means to insure and document that the manufacturing processes under his oversight represented best practices and would withstand FDA scrutiny.
Cyclotron facilities invest heavily in the technology needed to produce doses but many operators, ironically, fail to take advantage of today’s technology for the critical task of documenting compliance, SOPs and productions results.
BioTrax QMS gives you a paperless way to manage every aspect of your PET manufacturing facility, by integrating a central document repository to house:
a) raw material tracking,
b) production and quality control records,
c) operator training requirements and results,
d) equipment IOPQ documents, routine inspection reporting & maintenance records, and
e) facilities management documentation
The software offers customizable design, so all of your manufacturing documentation can be formatted with a user-friendly interface. The electronic repository stores all SOPs, training materials, spec sheets, and other documents in one location.
There are countless benefits to using BioTrax QMS:
Ease of reporting,
By simply querying the database, all the information that goes in can be extracted for FDA audit. Instead of having to retrieve records from secured filing storage and scouring through years of batch records, BioTrax users simply input search parameters and let the system do the work. The security of all records is insured with automated file backup technology and standard password protection.
In today’s market, you simply can’t afford compliance infractions or production delays. With up-to-date information, BioTrax QMS informs users of pertinent information and compliance issues.
Certification and testing
BioTrax allows administrators to create training documents and quizzes with minimum passing scores, as well as imposing frequency of retesting of employees.
Diminished room for error
Tracking batch records on paper is a risky business. Instead, by using electronic worksheets, ec2’s software can walk users through each manufacturing step and quality-control procedure.
Evolve beyond paper with BioTrax QMS to meet regulatory requirements for your cyclotron facility while efficiently managing your inventory, manufacturing and training. BioTrax QMS offers the best value for any automated solution of its kind. For more information on the functionality and benefits of our software, visit www.ec2software.com. To schedule a comprehensive demo of the software, obtain additional information or to request a proposal, call us at 800-851-0025 option 2.