Formal methods

Design space verification

Design space verification is defined by the European Medicines Agency as the verification that material inputs and processes are able to scale to commercial manufacturing levels while maintaining a standard of quality. Therefore, it is difficult to conduct design space verification while not operating at target levels and should be conducted over the manufacturing lifecycle. Changes in manufacturing output within the design space should not present any risks. Should the manufacturing load exceed the boundaries defined as normal operating ranges unanticipated scale-dependent issues can occur. Design space verification is a part of process validation as defined by the EMA in conjunction with the FDA. Its purpose is to guarantee end product quality within a range of manufacturing boundaries. The effects of scale up activities should be fully understood by the manufacturer. Most initial design space conclusions are based upon laboratory testing or pilot batches with scale up effects being inferred by experimentation or based on statistical evidence, simulations, or studies. Ongoing design space verification should be dependent upon the results of an assessment of risk involved with scale up activities. More specifically, how scaling up production affects scale-dependent variables. Design space verification is much more focused in scope than overall process validation. Design space verification specifically aims to confirm output quality within a given operating range. This allows for changes in operating level flexibility while guaranteeing production quality, and allows for changes in production quantities without necessitating a reevaluation of the production process. (Wikipedia).

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If you are interested in learning more about this topic, please visit http://www.gcflearnfree.org/ to view the entire tutorial on our website. It includes instructional text, informational graphics, examples, and even interactives for you to practice and apply what you've learned.

From playlist Design Thinking

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From playlist Space Construction

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From playlist Countdown to Launch | Seeker

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Take the full course: https://www.systemsinnovation.network/courses/7357542/ Twitter: http://bit.ly/2JuNmXX LinkedIn: http://bit.ly/2YCP2U6 Design thinking is a design process that enables us to solve complex problems. It combines deep end-user experience, systems thinking, iterative rapid

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Learn something new every week by subscribing to our newsletter: https://bit.ly/3tfAlYD Checkout our bestselling System Design Interview books: Volume 1: https://amzn.to/3Ou7gkd Volume 2: https://amzn.to/3HqGozy ABOUT US: Covering topics and trends in large-scale system design, from th

From playlist System Design Interview

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From playlist More

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From playlist Understanding Design

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In this video, you’ll learn how to broaden your definition of design through critical thinking, in order to see it in the world around you! Visit https://www.gcflearnfree.org/ to learn even more. We hope you enjoy!

From playlist Graphic Design

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At-scale Formal Verification for Industrial Semiconductor Designs - Professor Tom Melham

https://www.turing-gateway.cam.ac.uk/sites/default/files/asset/doc/1707/Big%20Proof%20Day%20Melham%2019-07-2017.pdf #TuringSeminars

From playlist Turing Seminars

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From playlist MIT 16.842 Fundamentals of Systems Engineering, Fall 2015

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From playlist Stanford EE380-Colloquium on Computer Systems - Seminar Series

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From playlist MATLAB and Simulink Conference Talks

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From playlist MathWorks Automotive Conference 2013

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From playlist Learning resources

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Related pages

Process validation