S-Matrix’s Fusion QbD® Software for LC Method Development and Validation – a comprehensive integration of chromatography centric and advanced statistical tools in an automated platform. The program has one-click experimental design (DOE), extremely precise chromatography centric modeling, comprehensive robustness simulation, and powerful new automated peak tracking and chromatogram visualization.
Fusion QbD includes a complete method validation experiment suite, provides full bi-directional experiment automation with the ChemStation, Chromeleon, and Empower Chromatography Data Software, and fully supports 21 CFR Part 11 compliance.
Fusion QbD can also be configured with modules for Formulation and Process Development, and Respiratory Drug R&D and QC.
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The Waters™ Empower™ software is a complex program. Many features are offered to help customers to obtain reliable results for their chromatographic measurements. Nevertheless, dealing with such a powerful product needs be learned and understood. Time and experience are needed. Often it can be discovered that the possibilities were not fully exploited. With me as a partner, you can trust in getting the most out of Empower™. Whether it's about implementation, switching-over ,release upgrade or operation of Empower™, I support at all stages, especially taking into account the current quality standards in the pharmaceutical industry.
USP 1058 requires a risk-based approach for the qualification of laboratory equipment. This is well understood in every GMP laboratory an not worth mentioning, but is usually not sufficient if the device is connected to a software system, which not only generates data, but also stores them in the long term. For the validation of the computer system the USP guideline gives little hints, here the GAMP5 provided by the ISPE offers orientation. At the same time, questions about compliance with data integrity are coming to the fore. cromingo has specialized in the validation of laboratory systems in chemical analysis, in particular Empower™, and can assist as a consultant, but also with the execution of the actual validation tasks.
As a service and distribution partner of S-Matrix® Corporation, cromingo® offers purchase, support, training and qualification for the S-Matrix® Fusion QbD® Software Platform in the DACH region and neighbored countries. cromingo® is your official point of contact for the Fusion software deployed for use with Waters™ Empower™ in german-speaking countries in all aspects.
Since 2006, working as a consultant for Empower™, you can rely on experience. Whether training, support with all questions of the operation, data integrity, audit trail review, creation of custom fields and reports, configuration or validation, with me you are at the right address. I support you in an advisory capacity, but you also implement it yourself.