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# Chromatography by Design

Specialized in Analytics & Informatics

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## Posts

- [Blog](https://cromingo.com/blog/)
- [Empower 3 Manual](https://cromingo.com/empower-3-manual/1883/) - Empower 3 Manual https://cromingo.com/empower-3-manual/1883/ Chromatography by Design admin Specialized in Analytics & Informatics
- [Is it really allowed to simply draw the line?](https://cromingo.com/is-it-really-allowed-to-simply-draw-the-line/1345/) - Manual Peak Integration under GMP - Just a Single Aspect During training courses, especially when customers have used other CDS systems than Empower before, I’m regulary confronted with the statement that manual peak integration, as it is e.g. technically implemented in the Empower CDS, is not acceptable from a regulatory perspective.participants argue that if only
- [Replication Strategy Optimization](https://cromingo.com/replication-strategy-optimization/1846/) - According to the AQbD principles defined in ICH Q2(R2), ICH Q14 and USP the number of sample prep and injections replicates should already be defined during the development stage of an analytical procedure.USP provides statistical tools that can assist in identifying a suitable number of replicates considering not only the precision of repeated measurements,
- [Best Practice in Peak Tracking](https://cromingo.com/best-practice-in-peak-tracking/1352/) - Best Practices in Peak Tracking One of the critical bootle necks for any chromatographic modelling is accurate peak tracking. Incorrect peak name assignments will consequentially lead to poor or even wrong predictions.Therefore, adequate care and time is required for this task. In order to facilitate peak tracking Fusion QbD offers advanced and fully automated peak
- [Robustness Simulation](https://cromingo.com/robustness-simulation/690/) - Learn how you could benefit from simulating robustness using Fusion QbD®.2302_FQbD – Robustness Simulation
- [Segmented Pump Gradient](https://cromingo.com/segmented-pump-gradient/706/) - Segmented Pump Gradients Returning from the HPLC conference in Dusseldorf, one of my lasting impression was, that the introduction of segmented steps into the gradient is still a promoted and accepted approach for optimizing an LC method.And no matter whether the method is developed manually or by any of the established modelling tools, this still
- [Assessing Gradient Robustness in FQbD 9.9.2](https://cromingo.com/elementor-1086/1086/) - Often some of our users miss an option in Fusion QbD® that allows them to shift the gradient in parallel around the setpoint, as this is the way they want to create a robustness design.From that request alone, it becomes clear that the Fusion approach is not fully understood.The request derives from the traditional way
- [Variation Flexibility with Gradient Steps](https://cromingo.com/variation-flexibility-with-gradient-steps/1096/) - Many of our customers have missed an option of varying several gradient steps in a single experiment. With Fusion QbD 9.9.2 much more flexibility for pump program variations is now provided.Please note, one reason, why Fusion QbD newbies want to use gradient steps, is because they are used to that from traditional approaches or other
- [Creating a Design - Study Factor Levels and Ranges](https://cromingo.com/creating-a-design-study-factor-levels-and-ranges/1127/) - When starting to adopt DOE in AQbD I noticed that even experienced chromatographers (or should I say especially this group?) often try to take over established routines when setting up their first experiments in Fusion QbD.Traditional approaches are often transferred one to one into a DOE-Design.This is espicially true, as Fusion QbD is a DOE
- [Maximum Expected Variation](https://cromingo.com/maximum-expected-variation/1134/) - In previous blogs we have provided explanation about robustness simulation in Fusion QbD and setting suitable distances between the single study factor levels.As explained in these notes, for both topics we need to know the expected maximum variation of our study factors.For this purpose, we usually refer to the vendor specification of the involved equipment
- [Considering Dwell Volume with Fusion QbD](https://cromingo.com/considering-dwell-volume-with-fusion-qbd/725/) - When setting up a design in Fusion QbD we recommend to always to start the pump program with an isocratic hold time (IHT). Still many of our customers wonder why we do this.Well one reason is of course, that one might identify better method conditions with IHT as additional study factor. But this shouldn’t be

## Pages

- [Home](https://cromingo.com/) - #chromatography software - chromatography modeling - cds software support germany- empower 3 training - s-matrix fusion qbd distributor
- [Fusion QbD](https://cromingo.com/fusion-qbd-423/) - Fusion QbD - #FusionQbD - #AQbD - #Chromatography Modelling - #DoE
- [Fusion QbD Webinars](https://cromingo.com/fusion-qbd-webinars/) - Fusion QbD® Public Webinars Course Title: Fusion Method Development Fundamentals Practitioner Certification Course In German or English, Conducted by a Certified Fusion QbD Trainer Webinar Key Topics Design of Experiments (DOE) MethodologyScreening and Optimization ExperimentsSpecial Considerations for Forced Degration Studies (FDS)Use of Automated Peak Tracking in Fusion QbDIntegrating Robustness in Optimization ExperimentsEstablishing the Method Operable
- [CDS Services](https://cromingo.com/cds-services/) - #Empower -#CDS - #Chromatography - #Empower_Training CDS Services
- [Our Business](https://cromingo.com/our-business/) - Our Business Since its foundation in 2018 Cromingo acts as a service and distribution partner for S-Matrix® Corporation. We offer sales, support, training and qualification for the S-Matrix Fusion QbD software platform in Central Europe with a special focus on German speaking countries. Thus, we want to be your direct point of contact for the
- [Document Library](https://cromingo.com/document-library/) - Download Area: Fusion QbD Short Courses/Technology Notes 2301_Adding Additional Compounds2302_Robustness_Simulation2304_Segmented Pump Gradient2305_Dwell_Volume_Consideration2306_Gradient_Robustness2307_Gradient_Steps_Variations2308_Defining Design Levels and Ranges2309_Maximum_Expected_Variation2401_Best Practice in Peak Tracking2403_Replication Optimization Strategy Fusion QbD - General FQbD 9.9.2 - New FeaturesFQbD 9.9.2 - Introduction_ENFQbD 9.9.2 - Inroduction_DEFQbD 9.9.2 SR2 - Supported Instruments and CDS SystemsFQbD 9.9.2.SR3a - Supported CDS Systems and LC PlatformsFQbD - CredentialsFQbD_Verification_Auto_MLR_FAE_Montgomery0113FQbD_License
- [Cookie-Policy (EU)](https://cromingo.com/cookie-policy-eu/) - This Cookie Policy was last updated on June 25, 2025 and applies to citizens and legal permanent residents of the European Economic Area and Switzerland.1. IntroductionOur website, https://cromingo.com (hereinafter: "the website") uses cookies and other related technologies (for convenience all technologies are referred to as "cookies"). Cookies are also placed by third parties we have
- [Disclaimer](https://cromingo.com/disclaimer/) - Disclaimer Liability for content As a service provider, we are responsible for our own content on these pages in accordance with general laws according to Section 7 Paragraph 1 TMG. However, according to Sections 8 to 10 TMG, as a service provider we are not obliged to monitor transmitted or stored third-party information or to
- [Privacy Policy](https://cromingo.com/privacy-policy/) - Privacy Policy for cromingo e.K. At www.cromingo.com, accessible from www.cromingo.com, one of our main priorities is the privacy of our visitors. This Privacy Policy document contains types of information that is collected and recorded by www.cromingo.com and how we use it. If you have additional questions or require more information about our Privacy Policy, do
- [Imprint](https://cromingo.com/imprint/) - ImprintAccording to § 5 TMG:Ingo Greencromingo e.K.Klosterufer 224582 BordesholmContact:Telephone: 04322/4431403Fax: 04322/4432887Email: info@cromingo.comKiel District Court (Amtsgericht Kiel)Registration number HRA 11012 KISales tax identification number (Umsatzsteuer-Identifikationsnummer)in accordance with Section 27 a of the Sales Tax Act:DE317032716The European Commission provides a platform for online dispute resolution (OS): http://ec.europa.eu/consumers/odr You can find our email address in the legal notice

## Categories

- [Blog](https://cromingo.com/category/blog/)
- [News](https://cromingo.com/category/news/)
- [Literature](https://cromingo.com/category/literature/)

## Tags

- [Robustness](https://cromingo.com/tag/robustness/)
- [MODR](https://cromingo.com/tag/modr/)
- [Dwell volume](https://cromingo.com/tag/dwell-volume/)
- [Initial Hold Time](https://cromingo.com/tag/initial-hold-time/)
- [Method Transfer](https://cromingo.com/tag/method-transfer/)
- [Gradient](https://cromingo.com/tag/gradient/)
- [FQbD992](https://cromingo.com/tag/fqbd992/)
- [Design](https://cromingo.com/tag/design/)
- [Ranges](https://cromingo.com/tag/ranges/)
- [Levels](https://cromingo.com/tag/levels/)
- [Variation](https://cromingo.com/tag/variation/)
- [FusionQbD](https://cromingo.com/tag/fusionqbd/)
- [Fusion QbD](https://cromingo.com/tag/fusion-qbd/)
- [Segments](https://cromingo.com/tag/segments/)
- [Empower](https://cromingo.com/tag/empower/)
- [Peak_Intergration](https://cromingo.com/tag/peak_intergration/)
- [Manual_Peak_Integration](https://cromingo.com/tag/manual_peak_integration/)
- [Audit_Trail](https://cromingo.com/tag/audit_trail/)
- [Data_Integrity](https://cromingo.com/tag/data_integrity/)
- [Chromatography_Modelling](https://cromingo.com/tag/chromatography_modelling/)
- [Optimization](https://cromingo.com/tag/optimization/)
- [PeakTracking](https://cromingo.com/tag/peaktracking/)
- [ICH Q14](https://cromingo.com/tag/ich-q14/)
- [ICH Q2(R2)](https://cromingo.com/tag/ich-q2r2/)
- [AQbD](https://cromingo.com/tag/aqbd/)
- [APLM](https://cromingo.com/tag/aplm/)
- [Replicates](https://cromingo.com/tag/replicates/)
- [Literature](https://cromingo.com/tag/literature/)
- [Manual](https://cromingo.com/tag/manual/)