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This blog post shares some of the challenges, opportunities, and best practices for building a robust data platform that will enable AI in a way that supports GxP compliance. Discover why it comes down to data availability and infrastructure to ensure that your models are reliable, secure, and easily accessible for regulatory scrutiny.
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All the buzz around AI has life sciences companies wondering how emerging technologies can be applied to advance validation processes and improve quality management. VEQTOR’s team examines ways generative AI can be put to work to make real-time verification and seamless integration with digital ecosystems possible.
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The relationship between quality and sales team is not only crucial, but it can transform a company and drive unprecedented successes. Lotus Business Solutions’ Christina Pecoraro examines how this relationship can result in more positive customer experiences and company growth.
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With FDA product recalls on the rise, life sciences companies need help navigating the intricacies of regulatory compliance and quality management. This blog post provides recommendations to help manufacturing and quality professionals effectively manage product quality issues, avoid receiving FDA Form 483 observations, and proactively prevent recalls.
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Navigating ICH guidelines presents significant challenges for pharmaceutical manufacturers. This blog post explores the key difficulties in interpreting guidelines, adapting existing systems, and ensuring consistent application across departments. It offers practical solutions, emphasizing the role of modern pharma QMS software in overcoming these hurdles. Discover how leveraging technology can streamline compliance efforts, drive operational efficiency, and improve product quality.
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As quality and compliance standards in pharma become higher and stricter, the shift from error-prone manual processes to operationally robust, fully digitalized processes can no longer be considered optional. Elemental Machines’ Dan Petkanas explains why it’s critical for pharma manufacturers to embrace digital maturity.
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As life sciences companies grow and evolve, their quality management systems (QMS) must keep pace. A QMS that was once good enough to get the job done might now be hindering your operations. Learn the five signs indicating it's time for a QMS upgrade.
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The fallout from FDA recalls can be profound, leading to massive financial losses, reputation damage, and even legal consequences. Find out what the new “Ultimate Guide to FDA Product Recalls” says about the upstream impact of recalls and how life sciences companies can prevent them.
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Discover how investing in a pharma MES can significantly improve your ROI by streamlining cGMP compliance efforts and minimizing hidden costs. Learn about the benefits of automating key processes, reducing errors, and streamlining audits. Download our free Manufacturing Software Buyer's Guide to learn more and start exploring how MasterControl MES can transform your operations.
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Generative artificial intelligence (AI) tools aren’t intended to replace humans. Rather, they’re designed to assist and augment them. Learn the benefits of taking a collaborative approach to using AI and how modern tools like MasterControl’s Exam Generator let humans actively guide and refine AI output.
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A new MasterControl survey report on FDA product recalls highlights the disconnect between consumer awareness and action, how recalls erode trust in life sciences manufacturing processes, generational differences in recall responses, and strategies for rebuilding trust. Take a deep dive into the report’s examination of the long-term impacts of recalls and learn why effective product recall management is essential for companies to maintain consumer trust and protect brand reputation.
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Nothing is more important to manufacturers in the life sciences than ensuring product quality. Learn how integrating QMS and MES in a single platform helps life science manufacturing organizations improve product quality, achieve greater efficiency, and accelerate regulatory compliance.
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Many medical device companies are wondering how the FDA’s Quality Management System Regulation harmonization will impact their quality management systems. No matter the complexity of your QMS or medical device, here are three simple steps device manufacturers should take to simplify the transition to the QMSR.
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How can medical device companies evolve and grow in the increasingly complex world of compliance and technology? Find out how Veranex overcame regulatory and efficiency challenges by implementing an advanced quality management system.
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Managing risk is challenging in the evolving pharma landscape. Discover how a proven quality management system can help pharmaceutical companies overcome common risk management challenges and achieve operational excellence.
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In their industry experience, AVS Life Sciences experts see six common barriers that companies face in their software validation efforts. In this blog post they offer tips on making validation less challenging, overwhelming, and time-consuming.
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Thinking of implementing a new quality management system or electronic batch record solution? Batchwize CEO Rebecca Waterbury examines how the benefits can outweigh purchase and implementation costs and explains how experienced consultants can help you get the most bang for your buck.
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Managing a diverse supplier network presents challenges like maintaining visibility, mitigating risks, and ensuring regulatory compliance. This blog post takes a closer look at these challenges and examines how a digital quality management system (QMS) can be a powerful tool to help medical device manufacturers overcome them.
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In medical device manufacturing, precision and efficiency aren't just buzzwords — they're essential for success. Yet many manufacturers are stumbling when it comes to a critical aspect of their operations: resource planning. In this blog post, planeus’ Sunny Mak offers proven, helpful manufacturing resource planning strategies.
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Quality consistency begins where continuous improvement intersects with your quality management system. L2Business Network’s Em Glassie recommends these continuous improvement strategies for eliminating waste and improving product quality.
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