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GINA X CDS - Centralized Data Solution -
calibrator are typical needed to confirm that the products are fully compliant to pharmacopeia or FDA regulations and standards. GINA X will lead you through the entire workflow from the first measurement until signing of the QC analysis certificate... client/server architecture allows an easy centralization and access to the instruments and data from different PC’s. With all data stored in the central SQL database, it is easy to secure the data integrity and be fully GMP and 21CFR part11 compliant.
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SARA - Smart Automatic Report Analysis -
Producten & Software Software Chromatografiesoftware - SARA is a central data recording and reporting system for all quality control data for production batches. Authorities require complete documentation of radio-pharmaceutical production, covering raw materials, production process, quality control and aseptic processing. For quality control, Elysia-raytest has developed a fully automated solution for the digital data transfer and reporting of all relevant data. In combination with GINA X and
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Endosafe -
, real time endotoxin assay.The PTS is perfect in a conventional quality control setting and is fully implemented in Elysia Turn-Key solutions.The Endosafe uses LAL kinetics chromogenic methodology that measures a colour intensity that is directly
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AURAS -
Elysia - Producten & Software Kant-en-klare pakketten AURAS Prep Module - AUTOMATE YOUR QUALITY CONTROL SIMPLE, INTUITIVE OPERATION FULLY COMPLIANT FLEXIBLE LOW RUNNING COSTS The AURAS concept is an Automated Radioactive Sample-handling module allowing you to upgrade your current quality control of radiopharmaceuticals. It is a new concept for the automated quality control of radiopharmaceuticals. AURAS has been designed to provide users with the flexibility they need for the analysis of many
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