cromingo® is a young freelance consulting company based in Berlin, which has set itself the goal of supporting customers in the implementation of the stringent quality requirements for the analytical pharmaceutical laboratory. Numerous pharmaceutical companies in German-speaking countries and abroad are already part of the company's established clientele.
Implementation, validation and operational support of laboratory data systems, in particular for the chromatographic analysis, and the lifecycle management of analytical methods according to AQbD approaches are among the core competencies of the business.
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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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.
Through my many years of activity in the industry, cooperations have also emerged. Even though I am on the road as a "lone fighter" and can not offer everything myself, I will find a suitable solution.