Standards
In an eco-friendly plot twist that would make Captain Planet proud, the European Union has rolled out the Corporate Sustainability Reporting Directive (CSRD), a blueprint that’s got big companies talking about more than just profits. Imagine a world where every major company’s reports don’t just…
In regulated industries like pharmaceuticals, medical devices, and food manufacturing, compliance is crucial for operational excellence. A validated quality management system (QMS) is key to maintaining this compliance. Let’s explore how QMS software streamlines validation and ensures regulatory…
In the ever-changing world of quality management, the intersection of innovation and standardization offers both exciting opportunities and tough challenges. Maria, a dedicated and certified quality professional, struggled with the concept of “standardizing innovation”—something that seemed like…
The U.S. Food and Drug Administration (FDA) recently published new guidance on conducting clinical trials with decentralized elements. It offers recommendations for sponsors, investigators, CROs, and other parties that are interested in implementing decentralized clinical trials.
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In a competitive manufacturing industry, meeting high standards is crucial to quality, sustainability, and safety. While it can be challenging to earn customer trust and establish a positive brand reputation, third-party certifications to standards such as IATF 16949: Automotive Quality…
The clock is ticking. Our planet is heating up, and with every passing day the stakes rise. Wildfires, floods, and storms are no longer distant headlines; they’re unfolding right on our doorstep. Humanity stands at a crucial turning point. But amidst the climate crisis, a powerful ally emerges…
