November 24, 2025
Leveraging CAPA Metrics to Advance Patient-Centric Continuous Improvement In the life sciences sector, the Corrective and Preventive Action (CAPA) process is far more than a regulatory obligation. It is a strategic engine for enhancing patient outcomes, operational consistency, and organizational resilience. When implemented proactively and supported by robust performance metrics, CAPA becomes a catalyst for […]
November 17, 2025
Beyond Compliance: Building a Culture of Learning Through CAPA In the pharmaceutical and life sciences industry, the Corrective and Preventive Action (CAPA) process is one of the most powerful yet often misunderstood mechanisms for driving sustainable quality improvement. At its core, CAPA is not simply a compliance tool; it is a structured framework for organizational learning, systemic correction, and continuous prevention. […]
November 10, 2025
When the Food Safety Modernization Act (FSMA) became law in 2011, it marked the most sweeping reform of U.S. food safety laws in more than 70 years. Its goal was clear: shift our national approach from reacting to foodborne illness outbreaks to preventing them. For quality professionals, this change meant more than regulatory updates; it […]
November 3, 2025
Design control is one of the most critical elements in the development of medical devices. Far more than a regulatory checkbox, it is a structured framework that transforms innovation into safe, reliable, and effective products. By embedding quality and risk management principles into every stage of development, organizations can enhance patient outcomes, streamline processes, and […]
October 27, 2025
2025 is shaping up to be another highly active year for the FDA enforcement of Current Good Manufacturing Practices (cGMPs). As I have been reviewing 2025 warning letters, one thing is clear: the same themes keep surfacing across different companies, product types, and geographies when it comes to FDA Enforcement. What strikes me is that […]
October 20, 2025
In September 2025, the U.S. Food and Drug Administration (FDA) issued a new guideline titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications”. Purpose and Scope This article outlines how the FDA intends to leverage innovative approaches—beyond traditional on-site inspections—to evaluate the readiness and compliance of facilities named in new drug applications (NDAs), abbreviated […]
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