Quality services for the analytical laboratory
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.
Fusion QbD®
state of the art software for the development and validation of chromatography methods - 100% QbD alligned (ICH Q8(R2)
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.
Some impressions on labtube.tv:
All video clips on labtube.tv
csv aligned with gamp5
validation of laboratory software.
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.
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local representation for Fusion QbD®, training, consulting, service, distribution
ICH compliant. automated. should not be missed in any analytical development department
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.
fusion qbd®
where can I support?
my portfolio in overview
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.
portfolio
cooperations
networking is the key to success
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.
cooperations
events and announcements
february 26-27: AWS Summit 2019 in berlin
Bringing technologists in Germany together to connect, collaborate, and learn about AWS. During this free, two-day event, you will learn about the AWS platform through breakout sessions that cover a wide range of topics from new services and architecture to performance and operations.
aws.amazon.com/event/summits/berlin
may 23: First Waters Empower AWS Cloud Installation in Switzlerand at Medinova AG
With the support of cromingo for planning and validation, the Empower installation has been migrated to the AWS Cloud. The project included not only the validation of the new GAMP5 installation, but also an inspection of the previous system and an update of all procedures for operating a CDS system under GMP conditions to meet the high regulatory requirements for data integrity throughout the whole system and data lifecycle.
www.dksh.com/ch-en/home/media/news
june 16-20: hplc 2019 in milan - booth 3
Visit cromingo at the booth of S-Matrix.
Take the chance to personally discuss with cromingo and the S-Matrix team the capabilities of the Fusion QbD software.
july 29: Fusion QbD 9.9.0 released
With Fusion QbD 9.9.0 you now get the long announced features: UV/MS Peak Tracking - Resolution Map Response - Support for Forced Degradation Studies.
By that, another breaking benchmarks is reached in creating a universal and productive DoE software for the development of chromatographic methods.
november 2019: PharmaLab-Kongress 2019 in düsseldorf
From the 11th to the 13th of November 2019, the event for all laboratory areas of the pharmaceutical industry will take place in Düsseldorf for the seventh time. For analytics, bioanalytics, microbiology and R &; D, this congress offers a wide range of lectures and an accompanying trade show with 10 interesting conference events.
This year, too, the S-Matrix® Corporation for the first time participates in the exhibition to promote the technology of Fusion QbD® to promote the software in German-speaking countries. Fusion QbD combines the full scope of a statistical design tool with features specifically designed to develop LC methods to deliver high-precision predictions for identifying optimal LC method conditions. Meet cromingo there, too, I look forward to your visit at booth 13.
