Matrix Gemini PET LIMS ‘gives full traceability from start to finish’
Autoscribe’s Matrix Gemini PET LIMS is ideal for giving full traceability throughout the entire process, from incoming raw materials through the production of PET Radiopharmaceuticals to finished products.
The commercial, off-the-shelf laboratory information management system was developed in conjunction with leading hospital-based PET centres in Denmark.
At each stage of production only tested and approved materials are available from the inventory to be used in the next step. The inventory is automatically adjusted as materials are used.
The LIMS also holds expiry dates for each item and those that have passed their shelf life are flagged and unavailable for use.
This full traceability backwards from a finished product allows scientists to see results and certificates of analysis for the raw materials used in the process.
If a full audit trail is required, all actions, time, date and user information are also recorded, and system and user actions are stored in the event log.
The Autoscribe LIMS also features a double sign-off system so scientists can not validate their own results, and Matrix Gemini PET LIMS also conforms to regulatory standards, including FDA 21 CFR11 and current cGMP and European regulations.
It offers fully configurable reporting, which can be shared by email or fax, and may be used on both web and desktop set-ups without the use of custom programming. This simplifies and speeds up the configuration process.
Users can store results against facilities, equipment and specific rooms for accurate quality control monitoring, and the document management system can store different types of documents and files from equipment lists and images to spreadsheets and personnel lists.
