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Visualizing Quality Culture Data – Analyzing 2 Scenarios

The following article is taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that expressed values […]

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The Scientific Basis of Quality Pulse®

The article below is a transcript taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. This section of the webinar focuses on the scientific basis of Quality Pulse. Introduction Edgar Schein was a researcher in the 1950s and ‘60s in organizational dynamics […]

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Reducing FDA Enforcement Risk: The Affordable 7-Step Approach

In 2020, COVID-19 — and more recently its Delta variant — wreaked havoc on an orderly return to business as usual. But recently progress has been made as the FDA said they have resumed some of its foreign inspectional activities and has begun transitioning to its standard operations for domestic inspections. But be forewarned, the […]

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A New Quality Culture Paradigm

The following article covers a transcript taken from June 15th Webinar – “Create a Quality Culture to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. The transcript covers a new quality culture paradigm section from the webinar. These two slides date back almost 20 years, and the FDA intuitively saw that culture […]

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Compliance Architects and CherryCircle Software Announce Exciting, New Partnership to Drive Best-in-Class Drug Development

Compliance Architects® is pleased to announce that it has partnered with CherryCircle Software to support implementation and on-going support needs of CherryCircle’s clients. QbDVision Platform CherryCircle Software has developed a one-of-a-kind platform (QbDVision Digital CMC™) that brings state-of-the-art digital infrastructure to pharma and biotech process development. The result: a platform purpose-built to accelerate the drug […]

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What Makes Quality Pulse Unique?

The following article a transcript from the “How is Quality Pulse different from other tools on the market?” video with Teresa, Kenneth, and Jerry. Jerry Appert: Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one of the questions I started thinking […]