/// aktuell + + + June 2019: cromingo® is exhibitor at HPLC 2019 in Milan - booth 3 with S-Matrix Corporation - Presenting the Fusion QbD® software + + +
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Empower™ with expertise. partner in all phases.

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.


Fusion QbD® für Empower™

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.


csv

local representation for Fusion QbD® (Empower™), 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®

publications

compact, understandable and helpful.

During my years of experience as a consultant for the Empower™ software I have created a guide to the Empower™ software. This can now be found in many chromatography laboratories, where it is hugely popular, making Empower™ newcomers easier to get started with, but also appreciated as a compact reference guide by experienced Empower™ users. I am very pleased that this book has served its purpose. You will find up-to-date documentation online here.


publications

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, 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

employee training and more

seminars, workshops, coaching - it's up to you

Especially in the regulated environment of the pharmaceutical laboratory, it is important to train the employees in a qualified way. I want to be your first contact for Empower™. I can advise you determining your needs and identifying the right training methods. Benefit from my many years of experience and my personal claim to qualify your employees sustainably. Only when my customers are satisfied, I will be satisfied myself.


qualify

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.


www.hplc2019-milan.org




events 2018