Quality Culture

The DNA of a life sciences business must believe that a substantial value for quality must be fully expressed in its DNA. Quality Culture is

Opening SceneFast forward to the Closing of the First SceneFlashback to the InspectionBack to the Closing of the First SceneNow What?How Do You Select the

MedTech: A Growing Industry for Mergers and Acquisitions The MedTech industry creates life-changing products to improve patient care. Companies in this field often merge, buy,

In the dynamic and high-stakes world of life sciences, maintaining a consistent and robust quality culture is not just a goal—it’s a necessity. A leading

From May 13th to 15th, Compliance Architects attended the 2024 Pharma Manufacturing World Summit. The event gathers SVPs and VPs of Manufacturing, Quality, Supply Chain,

The Cost of Poor Quality (COPQ) in the healthcare sector—particularly in medical devices, pharmaceuticals, and biopharmaceuticals—has profound implications for patients, employees, and shareholders. This analysis

In today’s rapidly evolving regulatory landscape, ensuring a robust quality culture is essential for any organization in the biopharmaceutical industry. Our latest infographic, “NAVIGATING YOUR

Joseph Juran once defined a Quality Culture as “a culture throughout the organization that continually views quality as a primary goal. It represents the emotional

Maintaining a robust quality culture cannot be overstated in the high-stakes world of life science manufacturing. The FDA-regulated industry is characterized by stringent requirements that

“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical

Quality Culture- Everybody wants it, and many say they have it. It begins with a diagnosis… Flash Back To 1964Fast Forward To 2014TodayRecommended Process for

This is the third in a series of articles on Quality Culture in the Medical Device Industry. Read article 1 here: Why is Achieving a

This is the second in a series of articles on Quality Culture in the Medical Device Industry. For the first article in the series, click

A Quality Professional’s Perspective on why Change Management Efforts Fail Top Management Support Resistance to Change Failure to Address Stakeholder Concerns Conclusion Contact Us A Quality Professional’s Perspective on why

Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the

“How did you go bankrupt?” Bill asked.   “Two ways,” Mike said. “Gradually and then suddenly.”   -Ernest Hemingway, The Sun Also Rises.  Gradually, Then SuddenlyA Slow, Rippling,

Quality culture, a term that has been gaining traction in regulatory compliance, is taking center stage in the life sciences industry. In a recent webinar

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

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

The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products.

Quality Pulse® has several use cases which it adds value to an organization. I’ll give 4 as an example, here. 1st occurs very often, a