Regulatory

Laboratory Information Management System (LIMS)

PETra LIMS: The PETra LIMS was installed in 2014 and used for data collection, storage and reporting of PET radiopharmaceutical production. This includes monitoring from irradiation to final product release (radionuclide production, synthesis, QC, product release). This unique laboratory information management system controls all aspects of radiopharmaceutical development and compiles all necessary information into an electronic batch report.

  • Communicates with cyclotron, synthesis box, and QC equipment
  • Aids in production planning/setup
  • Electronic Batch reporting (GLP/GMP compliant)
  • Embedded standard operating procedures to minimize human error
  • Notification of Corrective And Preventative Action (CAPA), Out Of Specification (OOS) and Deviation module
  • Advanced Inventory/stock control (barcode driven) for raw materials and reagents

Current Good Manufacturing Practices

Information coming Spring 2016!