BioTrax QMS

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 ensures in combination with GINA X data acquisition and evaluation simple and automatized data collection from Quality Control and synthesis.

The centralized solution is based on a SQL database. The client/server architecture allows an easy centralization and access to the instruments and data from different PC’s. With all data stored in the central SQL database, it is easy to secure the data integrity and be fully GMP and 21CFR part11 compliant.