Keeping track in radiotracer production for PET imaging

The production and handling of radiotracers used in positron emission tomography (PET) imaging techniques requires careful control and tracking of the materials being used. Autoscribe Informatics has introduced the Matrix Gemini PET Laboratory Information Management System (LIMS) configuration for this purpose. Developed in collaboration with two hospital-based PET centres, this affordable LIMS solution gives full traceability for regulatory compliance from incoming raw materials through the production process to finished products. It has been designed for use in PET Production, Radiotracer and Radiopharmacy facilities.

Full traceability

Matrix Gemini PET LIMS enhances traceability and accountability by auditing all actions. 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. Complete inventory management with expiry dates is provided so at each production stage only tested and approved materials available in the PET-LIMS inventory may be used, with the inventory automatically being decremented as materials are used. Expired materials are flagged and are unavailable for use in synthesis.

Matrix Gemini PET-LIMS contains 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. 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). 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. All files stored within the database are version controlled with full audit trail. Fully configurable reporting is a standard feature of the product and, if appropriate, reports and certificates of analysis can also be e-mailed or faxed.

The user can 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 (ICMS) module. ICMS keeps a computerised record of all instruments within the laboratory and a history of calibration and maintenance events for audit purposes. This helps to ensure only properly calibrated and maintained instruments are available for use. Further options permit the tight integration of laboratory instruments and external business systems with the product. Business management capabilities include the creation of quotations, order booking, allocation of appropriate prices and the production of invoices either directly or in conjunction with a corporate accounts system.

Ease of use

With a web browser user interface provided as standard, Matrix Gemini PET-LIMS may be deployed for use with both web and desktop systems. Both web and desktop systems can be configured in a single pass using Autoscribe’s unique configuration tools. These allow free choice of screens, workflows and menu designs and much more to meet the exact requirements of individual facilities, 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 is designed for use in both highly regulated and unregulated laboratories. It has the tools and design to help with compliance to cGMP, FDA 21 CFR Part 11 and current European regulations.

 

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