Essential QC Tools for GLP/GMP Environments
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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.
