When Would A Company Consider Using Quality Pulse?
Using Quality Pulse® has several use cases that add value to an organization. I’ll give 4 as an example, here. Quality Systems Improvement Initiatives The company is undertaking a quality systems improvement initiative in which they are revising their procedures and systems. It may be driven by a regulatory audit, an internal audit, continuous improvement, […]
Essential Elements for Supply Chain Optimization and Acquisition Integration in the Life Sciences Industry
The MedTech, Biopharmaceutical, and Pharmaceutical industries face growing complexity in managing end-to-end supply chains while balancing customer service excellence and cost efficiency. As companies pursue growth through acquisitions of platforms and businesses, the challenge of integrating these newly acquired entities into a cohesive and optimized supply network becomes increasingly significant. The pressure to deliver high-quality […]
Preserving Quality Culture Post-Acquisition
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 essential in healthcare; it directly impacts patient outcomes and operational efficiency. This article will describe the importance of preserving quality culture after an acquisition. The Role of Mergers and Acquisitions in […]
Remediation of Quality and Compliance Issues: The Good, the ‘Meh,’ and the Ugly
Let me set the stage… Opening Scene The FDA has just concluded what began as a routine, general inspection. The FDA Form 482 was served by the FDA Investigator(s), signaling the start of the inspection. The lead FDA Investigator outlined the purpose of the visit and estimated it would take four to five days. The […]
How a Strong Quality Culture Drives Successful Acquisitions in MedTech
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, or sell to grow their businesses. But these deals do not always succeed. Problems can arise when companies do not plan well or fail to focus on quality. A strong […]
Enhancing Quality Culture with Quality Pulse®: A Case Study
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 global life sciences company recently faced significant challenges in aligning its high standards of quality with the day-to-day experiences of its employees. Despite having comprehensive quality protocols in place, a […]
PMWS 24: New Pharma Manufacturing Insights
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, Technical Operations Executives, and other industry professionals to share pharmaceutical manufacturing insights and trends. These industry leaders are responsible for making pivotal decisions that shape the pharmaceutical industry’s future. Our […]
Cost of Poor Quality (COPQ) in Healthcare
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 delves into the impact of the cost of poor quality across these key stakeholder groups. Impact on Patients Poor quality in healthcare can lead to severe consequences for patients, including: […]
Navigating Your Quality Journey: Crafting a 3-Year Road Map
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 QUALITY JOURNEY,” offers a clear visual guide on how Compliance Architects can help you map out your quality strategy over the next three years. See the infographic below. The Journey […]
Transforming Success: Building a Quality Culture from the Ground Up
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 landscape of human habits, beliefs, commitments, awareness, and behavior concerning quality.” This profound definition summarizes what sets successful organizations apart from their less prosperous counterparts. A robust quality culture is […]
