New QMSR Risk Management Transition
Introduction to the QMSR Risk Management Transition The initial articles in this series focused on key differences a company needs to be aware of as they transition from the Quality System Regulation (QSR) to the Quality Management System Regulations (QMSR). For article 1 in this series that focuses on the QMSR introduction, click here. For […]
Integrated Quality Assurance Systems: Clinical Trials
The notion that the role of Integrated Quality Assurance Systems in clinical development should be relegated to reviews, audits, and quality control (QC) checks is an old-fashioned one. This could well run medical product developers afoul of FDA and international regulations. The Role of Quality Assurance (QA) in Clinical Trials The role of QA in […]
QMSR Transition Definitional Differences: Important Guide
Definitions matter. In cases of compliance, they matter a lot. That is why it is worth spending some focused time reviewing the QMSR transition definitional differences being implemented. As stated in my prior article (click here for article #2 in this series), Definitional Differences In section 3 “Terms and Definitions,” ISO 13485:2016 has 19 entries, […]
Important Differences: 21 CFR 820 QSR transition to QMSR
From the Top: Key Differences in the QSR transition to QMSR This is the second in a series of articles concerning the FDA’s proposal to transition 21 CFR 820 from the Quality System Regulation (QSR) into the Quality Management System Regulation (QMSR) by incorporating the ISO 13485:2016 standard by reference. To read the first article in this […]
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 […]
What is CRPN Quality Roadmap®? A Game Changer for Compliance
What is CRPN Quality Roadmap®? There was a moment in my career as a regional VP of Quality responsible for several large production sites, 25 large contract manufacturers, and thousands of suppliers that I thought I would never figure out which five to ten CAPAs out of thousands were the highest priority for my region. […]
Transitioning to the Medical Device Quality Management System Regulation (QMSR)
This is the first in a series of articles on the new Quality Management System Regulation (QMSR). The QMSR was published as a final rule on January 31, 2024 with an effective date of February 2, 2026. This series is intended to help companies fully prepare for the complicated journey ahead. Quality Management System Regulation […]
Quality Planning for FDA-Regulated Companies: The Cornerstone of Risk-Balanced Quality and Compliance Sustainability
In today’s FDA-regulated life sciences sector, where quality and compliance are not merely objectives but imperatives, robust quality planning should be a foundational activity to achieve a sustainable risk balance for sustainable quality and compliance outcomes. Given this, it is surprising to see from our work with clients that sometimes even the best, well-established companies […]
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: […]
GxP Best Practices Part 3: GMP Compliance in Outsourced Manufacturing
In session 3 of the Executive GxP Training, Teresa Gorecki and Jamie Colgin discuss how GMP compliance applies to companies that have outsourced all manufacturing operations. The training also discusses drug, biologics, and combination product GMP requirements for “virtual” companies. Company sponsors must comply with regulatory standards when outsourcing manufacturing for clinical materials, APIs, drug […]
