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Accelerate Innovation in Life Science Manufacturing: CSA Has Given You the License To Do It!

Using traditional waterfall and document-based approaches to validate computerized systems has hindered the ability of life science manufacturers to keep pace with the rapid innovations in technology. Recognizing this challenge, the FDA released new draft guidance aimed at facilitating the swift adoption of cutting-edge tech.

An Axendia, Inc. webinar brought to you by Tulip featuring AstraZeneca

Manufacturers are now empowered to adopt a risk-based assurance approach and focus on what’s really important: patient safety and product quality. Despite this guidance, many manufacturers are struggling to shift their old ways.

In this webinar, you will join industry experts from AstraZeneca, Axendia, and Tulip to hear how Life Sciences manufacturers are aligning operations and quality to quickly implement solutions and achieve value. In addition, you’ll hear how AstraZeneca has transformed its operations, successfully achieving digital adoption.

Top Takeaways:

  • Understand the basic objectives of systems validation and how to achieve it with current digital tools focusing on the intended use and risk to patient safety, product quality, and regulatory compliance

  • Understand how to move beyond a traditional validation approach and its reliance on non-value-added documentation to unblock your digital transformation

  • Explore real-world success stories on how to use the CSA approach to accelerate digital transformation


  • Headshot of Daniel Matlis

    Daniel R. Matlis

    President & Founder, Axendia, Inc

  • Headshot of Michelle Vuolo

    Michelle Vuolo

    Head of Quality, Tulip

  • Headshot - Bob Buhlmann

    Bob Buhlmann

    Head of Quality Digital & Computer Strategy, AstraZeneca