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How Hybrid Audits Can Help MDR Compliance in the European Union
The shortage of notified bodies (NB) in the European Union is a key challenge for device manufacturers struggling with Medical Device Regulation (MDR) compliance. As a result, the EU’s Medical Device Coordination Group (MDCG) is encouraging the use of hybrid audits. MDR, which took effect in May 2021, defines the rules for the sale of […]
8 CAPA KPIs You Should Be Measuring Now
Corrective and preventive action (CAPA) is a core function in any quality management system (QMS) and critical to the Plan-Do-Check-Act process approach. Like any quality process, tracking CAPA KPIs (key performance indicators) is crucial to continuous improvement. It’s also a focus of regulators and auditors, and is consistently highlighted in the more than 500 warning […]
Finding the Root Cause: Where Manufacturers Go Wrong
Finding the root cause of a manufacturing quality issue prevents unsafe or poor quality products from reaching consumers. Unfortunately, many investigations don’t get to the true root cause of a problem. As a result, mistakes continue, and poor product enters the market, increasing consumer risks and costs to remediate. Unfortunately, many FDA warning letters involve […]
5 Strategies to Improve Quality Incident Management and Root Cause Analysis
Imagine you’re doing a pre-shipment inspection on multiple pallets containing product canisters. As a result of the inspection, you observe wrinkled labels throughout the lot. While the defect is cosmetic, the issue still requires quality incident management to correct it. Some of the labels may not be legible and the lots risk being sent back. […]
AssurX to Attend ASQ Quality 4.0 Conference and Host CAPA Roundtables
RENO, NEVADA, UNITED STATES, October 4, 2022 — AssurX, a leader in quality management and regulatory compliance systems, will be attending this year’s ASQ Quality 4.0 Conference being held October 12-14, 2022, at the Grand Hyatt San Antonio River Walk in San Antonio, TX. About This Year’s Conference This year’s theme is Quality 4.0: AN […]
5 Building Blocks You Need for a Quality 4.0 Foundation
Market changes and disruptions such as the global pandemic are driving companies to adopt Industry 4.0 in their manufacturing operations. Many companies are investing in smart manufacturing by digitizing all levels of production. However, they have yet to grasp the concept of Quality 4.0 as a quality management strategy. Industry 4.0 is helping companies increase […]
Understanding ALCOA+ Principles and Data Integrity for Pharma
Data integrity is a cornerstone of U.S. Food and Drug Administration (FDA) current good manufacturing practices (cGMP) regulations. Pharmaceutical manufacturers must ensure data is reliable and accurate, following data integrity requirements in CFR parts 211 and 212. However, FDA data integrity guidance notes a “troubling” increase in cGMP violations related to data integrity in recent […]
Pharmaceutical Warning Letters Reveal CGMP Failures
Current good manufacturing practices (CGMPs) are the cornerstone of drug safety. However, it’s an area where many pharma manufacturers still struggle. In fact, 30 percent of FDA pharmaceutical warning letters issued in the first half of 2022 cite CGMP violations (Source: FDA.gov). FDA warning letters include many violations noted during inspections, including filthy production areas, […]
Why an EQMS is Essential for FDA Remote Regulatory Assessments
The global pandemic brought an unexpected change – FDA remote regulatory assessments (RRA). The FDA wants to expand RRA across all product areas to supplement in-person inspections after it has proven to be effective. The agency drafted the guidance under the FDA Good Guidance Practices regulation to explain its interpretation of RRA. The FDA will […]
EU MDR & IVDR Regulation: Where Does the Guidance Stand?
Companies marketing devices in the European Union are facing a perfect storm of EU MDR & IVDR regulation challenges. According to a 2022 Medical Device Coordination Group (MDCG) position paper, more than 90 percent of European medical device certificates are set to expire between 2023 and 2024. Meanwhile, just 30 NBs are handling 80 percent […]
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