January 29, 2025
by Anthony DeBiase, Director, Digital Process Development & Clinical Manufacturing, Continua Process Systems
Digital transformation provides an opportunity for life sciences manufacturers to streamline operations, ensure compliance, and maintain product quality. Discover how AI and other transformational technologies can augment core digital systems and how adopting digital systems empowers life sciences organizations to optimize production, enhance data integrity, and meet regulatory standards more efficiently.
FDA product recalls have increased 115% since 2018, posing significant risks to life sciences companies. This article explores the key factors driving recalls, their financial and reputational impact, and how implementing digital quality management solutions can help prevent them. Learn essential strategies for maintaining compliance and protecting your organization from costly recalls.
Artificial intelligence has emerged as a game-changing technology in various industries, and life sciences is no exception. This blog post explores how AI is reshaping life science quality management and why embracing this technology is essential for staying competitive in an evolving industry.
January 22, 2025
By Em Glassie, Partner and Director of Communication, L2Business Network
Quality can’t be inspected into a product; it must be designed into every key step. To help navigate this complex landscape, L2Business Network’s Em Glassie offers three compliance strategies every life sciences venture needs to succeed long term.
January 15, 2025
by Dustin Williams, ISO 17025 Consultant, Tech Engines
In pharmaceutical businesses whose processes rely on measuring equipment, the consistency and accuracy of measurement results is integral. Discover why the best way to reduce the risk involved with pharmaceutical equipment measurements is to make sure that the equipment is calibrated by an ISO 17025 accredited laboratory.
The digital disconnect rampant in life sciences manufacturing not only hampers efficiency but also introduces risks in a landscape where precision and compliance are paramount. Discover why the need for digital transformation in life science manufacturing goes beyond mere efficiency gains. Learn how your organization can overcome common challenges and achieve manufacturing excellence.
January 8, 2025
by Rebecca Waterbury, CEO, BatchWize and Kimberly Snyder, Executive VP Quality, Exemplar Compliance
Looking to optimize your pharma product release processes? The second installment of Batchwize’s two-part blog series on product releases focuses on strategies for effective planning, crucial QMS elements, setting appropriate product specifications, leveraging electronic systems, and the role of CMOs in the release process.
Product recall rates continue to rise – an alarming trend that underscores the urgent need for robust quality management processes in the life sciences industry. Discover how a comprehensive QMS can help your organization prevent quality issues that could lead to recalls.
December 18, 2024
by Rebecca Waterbury, CEO, BatchWize and Kimberly Snyder, Executive VP Quality, Exemplar Compliance
Part one of BatchWize’s two-part blog series covers the fundamental concepts of product release in pharma manufacturing, including its importance in ensuring drug safety and efficacy and the industry’s specific regulatory requirements. Learn about the data and records that are essential for a successful product release and discover why it's a comprehensive review process that entails far more than just signing off on executed batch records and SOPs.
Many life sciences organizations struggle to implement a comprehensive corrective action/preventive action (CAPA) system that satisfies both quality and regulatory requirements. Find out how optimizing CAPA processes helps companies improve overall product quality and safety while significantly reducing the risk of FDA observations and recalls.
Navigating the evolving landscape of FDA 510(k) compliance is crucial for medical device manufacturers. This article explores the challenges and opportunities presented by recent scrutiny and proposed modernization of the 510(k) process. Discover how industry leaders can adapt their strategies, embrace global compliance standards, and leverage technology to ensure both innovation and patient safety in an ever-changing regulatory environment. Learn to navigate the "twilight zone" of predicate devices and position your company for success.
Discover how to streamline your medical device commercialization process in our comprehensive guide. Learn key steps for optimizing cross-functional teamwork, quality assurance, and regulatory compliance using modern digital tools. Enhance efficiency, ensure compliance, and bring your innovations to market faster. Read more for valuable insights.
Discover how digital transformation is revolutionizing life sciences manufacturing. Learn from MasterControl experts about implementing connected QMS, overcoming integration challenges, and achieving remarkable ROI through paperless processes. Gain insights from real-world success stories and explore strategies for building a connected quality and manufacturing ecosystem. Don't miss this essential guide to future-proofing your operations.
December 3, 2024
by Melissa Leygan, Owner, eQMS Consulting LLC
What happens when one quality management process interferes with the best practices of another? Learn strategies from eQMS Consulting’s Melissa Leygan on evaluating conflicting practices, improving current processes, and achieving smarter optimizations.
November 26, 2024
By Leah Jones, CEO, QA Connect Management Consulting, LLC
Audits are valuable tools for evaluating a medical device company’s performance and ongoing conformance to regulatory guidelines. They promote continuous process improvement in the medical device industry and help companies avoid recalls. Learn the benefits of an effective audit program and strategies for improving the effectiveness of your organization’s auditing function.
November 21, 2024
by David Orr, CEO, Medpoint, LLC
When manufacturing medical devices or pharmaceuticals, ensuring the proper functioning and reliability of equipment, systems, and processes is crucial for producing quality health care products. And every aspect of production hinges on proper validation. This blog post takes a dive deep into the three essential components of validation – IQ, OQ, and PQ – and the significance of validation in life sciences manufacturing settings.
November 20, 2024
by John Spanomanolis, Senior Principal QA Bio Medical Engineer Consultant, Foton Consulting
Three key technologies are forging the future of medical device risk management. This blog post examines how risk management is changing in the medical device industry and the bright future that the three complementary elements are creating.
November 13, 2024
by Mohit Jumani, Managing Consultant, Enterey Life Sciences Consulting
Products, people, processes, premises, and performance function together to create a safe, compliant cGMP manufacturing operation that delivers reliable products. Find out why an organization-spanning focus on these 5 Ps is the key to compliance in today’s fast-moving and highly regulated pharma environments.
Discover how integrating QMS and MES revolutionizes life science contract manufacturing. Learn about key challenges, real-world success, and how MasterControl's innovative, user-friendly platform delivers ROI while ensuring quality, compliance, and operational excellence in the competitive CMO landscape.
November 5, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Even the slightest quality failures can lead to product recalls. Keep your guard up against recalls by learning about their primary causes, how the FDA classifies them, the four critical steps of recall response, and smart approaches that can help you avoid them altogether.
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