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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 […]
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 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 […]
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. […]
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 […]
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 […]
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 […]
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, […]
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 […]
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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