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Männedorf, Switzerland, April 28, 2016 –Tecan has unveiled a novel solution to help laboratories meet the stringent requirements of regulatory authorities such as the FDA and the EMEA. The new MultiCheck™ QC package for Spark® 10M and Spark 20M multimode readers comprises a reusable QC plate and accompanying data analysis software, and is designed to aid laboratories striving to fulfill increasingly strict regulatory demands including GLP, GMP, ISO 9001, ISO 13485 or Title 21 CFR Part 11.
Enabling verification of the correct functionality of all major components and key measurement modes over time, the new MultiCheck QC package for Spark readers allows complete Installation Qualification and Operational Qualification (IQOQ) of the reader in a single step. For fast, simple operation, the MultiCheck plate uses solid samples, eliminating tedious preparation and pipetting of test liquids. The plate’s absorbance reference is also traceable to NIST, ensuring the highest level of quality control. The powerful MultiCheck software guides the user through the entire process, documenting the operator identity, QC plate and reader serial numbers for audit purposes. All QC measurements performed using the Spark reader are rapidly analyzed, with detailed results for each test parameter documented in a comprehensive report.
To learn more, visit www.tecan.com/qctools
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Tecan (www.tecan.com) is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics and clinical diagnostics. The company specializes in the development, production and distribution of automated workflow solutions for laboratories in the life sciences sector. Its clients include pharmaceutical and biotechnology companies, university research departments, forensic and diagnostic laboratories. As an original equipment manufacturer (OEM), Tecan is also a leader in developing and manufacturing OEM instruments and components that are then distributed by partner companies. Founded in Switzerland in 1980, the company has manufacturing, research and development sites in both Europe and North America and maintains a sales and service network in 52 countries. In 2015, Tecan generated sales of CHF 440 million (USD 459 million; EUR 411 million). Registered shares of Tecan Group are traded on the SIX Swiss Exchange (TECN; ISIN CH0012100191).