Mike Cudemo

Downingtown, Pennsylvania, United States Contact Info
2K followers 500+ connections

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About

A trusted advisor who works with clients to identify, justify and plan enterprise-wide…

Activity

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Experience & Education

  • Sapio Sciences LLC

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Publications

  • Reducing Validation Time and Cost: How GAMP & Risk Based Approaches are Reducing Costs

    AskAboutValidation.com

    Beliefs drive behavior. Believing that validation has to be costly, lengthy and difficult is a self-fulfilling prophecy. GAMP-5, Lean, and Agile system development have teamed up. Where validation costs were assumed to be 20-25% of the total project cost, leading companies are driving these costs below 4%. This frees up working capital for real innovation.

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  • Agile vs. Waterfall – what is the big deal?

    Software Product Manager

    Seeing is believing. Agile methodologies are not perfect, but they are three times more successful than traditional waterfall methodologies (source: Standish Group). Agile methodologies allow end users and stakeholders to visualize their requirements faster and catch errors earlier in the development process.

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  • Accelerating Quality Outcomes

    Quality Digest

    Quality outcomes need to have the same speed and precision as ERP financials.

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  • Enterprise Quality Management Benefits

    Healthcare Packaging

    Packaging lines are becoming more and more automated. Losses are becoming more related to the input materials and thus an EQMS helps the packaging operations team work more collaboratively with their customers and suppliers to make sure the input materials maximize production efficiency and minimize costs.

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  • The Unexpected Benefits of Tracking Unexpected Results

    Sparta Systems Blog

    It is important to track events for later trending. If you only collect the information around big mistakes, you will always be making big mistakes and not preventing them.

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  • Why Speed Equals Quality

    Sparta Systems Blog

    If you can't roll up your state of quality quickly, chances are you don't really have a good understanding of the state of your product quality. Current quality systems are run like 1990's MRP - data silos, Excel spreadsheets and emails. The lack of speed in assembling your quality metrics points to blind spots that can really hurt you.

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  • We Hold These Truths

    Sparta Systems Blog

    The pursuit of quality, like our Grand Experiment and Constitution, is a work in progress!

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  • Quality is No One's Job

    Sparta Systems Blog

    CAPA systems are just as important as PLM systems that attempt to achieve quality by design. Many downplay the value of streamlined, well-intentioned CAPA system. If you are perfect, disregard this blog. If you are like the rest of us, you might find it interesting.

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