Guiding The Way

AN MKS COMPANY

The real QbD tool

www.umetrics.com

Products and ServicesENTERPRISE SOLUTIONS• Enterprise Platform – A tailored solution to meet your

company’s needs, including software, implementation, training and support

• PAT Suite – A tailored solution aimed at pharmaceutical production, including software, implementation, training and support

SOFTWARE PRODUCTS• MODDE – The standard for design of experiments and

optimization

• SIMCA – The standard in multivariate data analysis with built-in batch analysis

• SIMCA-online – The new standard in process monitoring and prediction, combined batch and continuous processes

INTEGRATED SOLUTIONS• SIMCA-Q – Family of real-time prediction engines (DLLs) for

system integration

• MODDE-Q – Design of Experiments to be integrated into any application

TRAINING — UMETRICS ACADEMYUmetrics Academy offers training courses on the following subjects:

• Design of experiments

• Multivariate data analysis

• QbD

• PAT

• Tailored in-house courses

CONSULTINGUmetrics provides complete consulting services including workshops, seminars, training, technical support and project management.

UMETRICS IS THE WORLD LEADER IN MULTIVARIATE TECHNOLOGY. We provide software for Design of Experiments and

Multivariate Data Analysis; tools that transform

your data into information, guiding you to confident

decisions and helping you understand complex

products and processes. We offer complete solutions

for off-line as well as on-line data analysis for

continuous and batch processes — all supported by

training and consulting services to ensure that you

get the most out of your data.

AN MKS COMPANY

MODDE, SIMCA, OPLS, and O2PLS are registered trademarks of Umetrics.

MODDE and SIMCA are compliant with 21 CFR Part 11 (Electronic Records). Major pharmaceutical companies have audited Umetrics quality systems for software development and validation. The audit trail is administrator-controlled and check-sum protected. SIMCA-4000 is OPC certified by the OPC Foundation

Build up knowledge & information from data

Gain value from data-driven decisions

data

inf

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atio

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information value

PROC

ESS

DATARepresents process

INFORMATION

DECISION

• FULLFLEXIBILITYWHENCREATINGTHEDESIGN

MODDE guides you in the design creation process by considering your initial specifications before recommending a design. MODDE can handle a combination of quantitative, qualitative and mixture factors as well as a constrained design region.

• GUIDANCETOSAFEANALYSISANDINTERPRETATION

The Analysis Wizard guides you through five steps of data analysis, displaying graphs and interpretation help to facilitate reliable interpretation. The new Square and Interaction test tools automatically detect unresolved nonlinear or interaction functions.

• GRAPHICALLYCONTROLLEDOPTIMIZER

The new intuitive graphs in the Optimizer help you understand what’s possible to achieve and decide when a compromise is needed

• RISKEVALUATIONATEVERYDECISION

Unique to MODDE is that you can estimate the system capability, based on a few designed experiments, and estimate parameter criticality with interactive graphics. The new integrated risk analysis toolbox presents a risk estimation on each decision.

• WILLFINDTHEMOSTROBUSTAREAWITHINYOURDESIGNSPACE

The Design Space is the region where all product specifications are fulfilled and meets the defined quality. The real challenge is to find the most robust point in this irregular and multidimensional region. MODDE is the solution!

D E S I G N • A N A L Y S I S • P R E D I C T — D E S I G N • A N A L Y S I S • P R E D I C T — D E S I G N • A N A L Y S I S • P R E D I C T — D E S I G N • A N A L Y S I S • P R E D I C T

Why MODDE 10? MODDE - TAKING QUALITY BY DESIGN (QbD) TO THE NEXT LEVELMODDE guides you through the set up of your Design of Experiments (DOE) and supports you in the subsequent data analysis. MODDE is the result of a close collaboration between our experts in multivariate technology and Six Sigma experts at GE. Together we have created unique capabilities that you won’t find elsewhere.

FOR CRITICAL APPLICATION AREASAs anyone in product development knows, getting things right from the start is a challenge, especially with so many parameters to take into account. For industries like Pharma, where outcomes are critical and the competition is fierce, you need tools that you can be sure will get you to the market on time.

FASTER,EASIEROPTIMIZATIONMODDE is the most effective software you can find for achieving product and process efficiency and optimization. Created specifically to help scientists, engineers and statisticians understand complex processes and products, MODDE is the only guide you need to reach a safe interpretation and evaluation when designing experiments. Its intuitive graphical interfaces and detailed data visualization combine to enable effective and accurate decisions.

BEYONDCLASSICALDOEWith MODDE we don’t stop at DOE. We empower you to simultaneously perform quality analysis without having to rely on other software. By integrating risk analysis visualization we go beyond classical DOE Contour and Sweet Spot plots. Our unique Probability Contour Plot introduces Monte Carlo simulation showing you where risks for failure exist, as well as the probability of achieving the results you need.

LEADING THE WAY IN DESIGN SPACE ESTIMATIONBecause classical overlay contour methods provide no assessment of risk, many solutions fall short in their contributions to QbD and Design Space estimation. MODDE leads the way, introducing real QbD and estimation of Design Space by taking into account uncertainties and variations in parameters, measurement systems and processes, and it works with up to 32 factors and multiple responses.