Matrix Gemini PET laboratory information management system (Lims) has been developed in collaboration with two hospital-based PET centres in Denmark.
The Lims gives full traceability from incoming raw materials through to the production of PET radiopharmaceuticals to finished products.
At each production stage, only tested and approved materials are available in the inventory to be used in the next step of production with the inventory automatically being decremented as materials are used.
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.
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.
Fully configurable reporting is delivered with the product and, when appropriate, these can also be e-mailed or faxed.
Where required, Matrix Gemini PET Lims may be further configured for use with both web and desktop systems.
Both web and desktop systems can be configured in a single pass using Autoscribe's visual workflow designer without the use of custom programming or writing of esoteric scripts.
This simplifies and speeds up the configuration process and reduces the validation and ongoing support and maintenance effort.
Matrix Gemini PET Lims also allows the user to store laboratory test results against facilities, equipment and rooms for quality control monitoring with the option to upgrade to include a full instrument calibration and maintenance module.
Further options permit the tight integration of laboratory instruments and external business systems with the product.
Within Matrix Gemini PET Lims is a document management system with capabilities for storing different types of documents and files from equipment lists to methods/SOPs, images, spreadsheets, photographs and personnel lists.
Files stored within the database are version controlled with full audit trail.
Multiple levels of access allow users to view the current version of a document while administrators can open, view, export and update documents as required.
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).
