A Matrix Gemini PET Production LIMS configuration has been developed in collaboration with hospital-based positron emission tomography (PET) centres in Denmark. This affordable solution gives full traceability from incoming raw materials through to the production of PET radiopharmaceuticals as finished products.
It is implemented to ensure that at each production stage, only tested and approved materials are available in the LIMS inventory to be used in the next step of production. The inventory is automatically decremented as materials are consumed. Expiry dates are held against each item with expired materials flagged and unavailable for use in synthesis. Full traceability allows a user to view results and certificates of analysis for all the raw materials used in production with all actions time/date/user-stamped for a full audit trail. Double sign-off can be implemented where appropriate so a scientist is not allowed to validate their own results.
Fully configurable reporting is delivered with the product and, when appropriate, these can also be e-mailed or faxed.
Matrix Gemini PET LIMS also allows the user to store laboratory test results against facilities, equipment and rooms for quality control/contamination monitoring with the option to upgrade to include a full instrument calibration and maintenance module.
Documents can be viewed from different points within the LIMS such as test methods being viewed at the testing stage and are automatically launched into the relevant program (for example Microsoft Word or Adobe Reader).
Matrix Gemini PET LIMS conforms to regulatory requirements such as FDA 21 CFR11 and current cGMP and European regulations. System and user actions are stored in the system's event log. Files stored within the database are version controlled with full audit trail.