Laboratory Information Management System (LIMS) for Radiopharmaceutical Production
Automated recording of all
QC relevant data
Customizable batch reporting
Fully GMP and „21CFR“ compliant
The raytest Raphaela RS (previews name was BARES Batch recording & reporting system) is a data base based LIMS system to acquire, record & report results out of the individual instruments radiopharmaceutical production. It records automatically & digitally the information required by law for the release of a radio-pharmaceutical tracer. This is mainly for 18F-FDG, but can also be used for other PET tracer like FEC, FET etc.. It can also collect data from the cyclotron, synthesis, QC & dispensing. It assemble automatically all those information to one common release report. This contains the measured value plus the information about the level of acceptance. It also remarks if one value is out of the acceptance criteria or the required value is missing. The final report will be digitally signed as released by the responsible person. Therefore the report is the release document for the final customer & the producer.
It also contains the data backup system for all individual instruments of the production.
The Raphaela RS system is running on a separated server computer system. It use a Firebird (Interbase) database to store all production information, QC result values & dispensing information. The Raphaela RS system can be configured individual related to the local authorities requirements & rules. Each required value of the individual analytical QC instrument will be transferred digitally automatically and controlled of correct receive. Therefore the 4 eyes principle is NOT required anymore!!! The configuration of Raphaela RS contains the level of release acceptance. If the received value is out of that level, the release will be refused. The required entries can be configured. For very specific customer requirements also manual entries can be added (remarked as manual entry). The user management describes the different level of users & their authorization up to the authorization to sign (release) the product. Also the configuration can be done country & language specific.