Remove solutions regulations FDA-compliance
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The FDA’s Adoption of ISO 13485: What Medical Device Manufacturers Should Know

Arena Solutions

A Global Quality System Standard As globalization of medical device supply chains has continued to increase, regulatory bodies have grappled with how to bridge the gap between domestic and foreign regulation. United States medical device manufacturers that already address ISO 13485 will have a leg up to address FDA regulations.

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Research, Trends & Insights: Digital Imperative for Life Sciences

QAD

For over 16 years, industry executives, technology innovators and regulators have trusted Axendia to provide analysis, advice and insights at the intersection of business, regulatory and technology domains based on trusted sources. ? ? ? ? ?. As organizations, we were extremely focused on compliance which made us very reactive. .

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10 Reasons Why You Need Cloud-Native PLM

Arena Solutions

As a result, many product development and manufacturing companies are investing in cloud solutions to help compete with bigger brands. Cloud-native product lifecycle management (PLM) solutions have become huge game changers for businesses of all sizes, especially small to midsized.

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From Requirements to Launch: Arena’s Expanded QMS Capabilities Help Speed Innovation

Arena Solutions

While much of this time is dedicated to conceptualization, prototyping, and testing, the approval process by regulatory bodies such as the Food and Drug Administration (FDA) and European Commission (e.g., To demonstrate compliance, cross-functional teams must regularly document, analyze, trace, prioritize, and agree on requirements.

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Validated, Real-Time Visibility for Pharma with Josh Allen

The Logistics of Logistics

Tive‘s solution provides data generated by its industry-leading trackers allowing clients to actively optimize their shipments, improve their customers’ experience, and unlock supply chain insights in an actionable real-time manner. GxP-compliant: Tive’s solution follows the guidelines of Good Manufacturing Practices (GMP).

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Improving Quality Management in F&B: Real Water Recall

QAD

How can food and beverage processors and manufacturers become better prepared to prevent potential safety issues and comply with future changes to regulations? In June, the FDA announced the company agreed to cease operations until it can comply with the Federal Food, Drug and Cosmetic (FD&C) Act and other requirements.

Quality 98
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The Ultimate Guide to QMS Software

Arena Solutions

To meet these goals, many organizations rely on enterprise quality management system (QMS) software solutions to get high-quality products to market fast. More and more organizations rely on a QMS to meet FDA, EU MDR, and ISO regulatory standards and reduce audit risks and consequences. ISO 9001 Compliance. The History of QMS.