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GxP Lifeline
  • Image of a medical device manufacturing professional working on the commercialization phase of the medtech product using a digital MES.

    Optimizing Medical Device Commercialization: A Quality Manager's Guide

    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.

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  • Image of MasterControl logo, offering connected quality management and manufacturing for the life sciences industry

    Building a Connected Quality and Manufacturing Ecosystem in Life Sciences

    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.

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  • Image of life sciences quality management professionals discussion QMS process optimization.

    What to Do When Optimization Conflicts With Process Needs

    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.

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  • Image of a medical devices professional working on an uaudit using a tablet

    Auditing in Medical Device Organizations: Why an Effective Audit Management Program is Essential

    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.

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  • Image of life science manufacturing professionals working.

    Achieving the Three Pillars in Life Science Manufacturing Validation

    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.

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  • Image of a medical device professional working on a digital QMS.

    The Future of Risk Management for Medical Devices

    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.

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  • Image of a pharma manufacturer working.

    The “5 Ps” of Operationalizing a cGMP Manufacturing Facility

    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.

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  • Image of a life sciences contract manufacturing professional working with a digital QMS.

    Revolutionizing Life Science Contract Manufacturing: Unifying QMS and MES for Optimal Performance

    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.

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  • Image of MasterControl’s infographic on FDA product recall prevention.

    4 Keys to Effective Product Recall Management

    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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  • MasterControl’s ultimate guide to FDA Recalls for Life Sciences Companies

    FDA Product Recalls: Understanding the Risks and Solutions for Life Sciences Manufacturers

    With a 115% increase in FDA recalls since 2018, it's clear that life sciences companies need to take proactive measures to protect their products, reputation, and bottom line. This blog post explores the causes of recalls, their impact on consumers and businesses, and how connected digital solutions can help you prevent them.

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  • Image of a digital MES in a life sciences manufacturing environment.

    Hardware That Works: How to Choose the Right Tools for Your Life Sciences QMS and MES

    Selecting the right hardware to support QMS and MES software solutions is a critical step life sciences manufacturers often overlook. Since it’s easy to be overwhelmed by the variety of hardware options available, DTG CEO Stephen Shaheen examines how to simplify those choices using a targeted and systematic approach.

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  • Image of a life sciences lab professional looking down a microscope.

    Navigating the FDA’s Final Rule for Laboratory-Developed Tests (LDTs)

    Nervous about changes to the regulation of laboratory-developed tests (LDTs)? This blog post provides an in-depth analysis of the FDA’s final rule, outlines the history and context of LDT regulation, and highlights the phases of implementation, challenges, and opportunities for laboratories and manufacturers.

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  • Image of a life science manufacturing professional checking an FDA product recall checklist.

    FDA Compliance and Product Recall Prevention Checklist

    When FDA investigators identify issues that could potentially lead to product recalls, they typically stem from quality failures like inadequate documentation, poor quality event management, and insufficient process validation. Find out how you can effectively address these vulnerabilities and significantly reduce the risk of an FDA recall.

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  • Image of a life science manufacturing professional using AI for their GxP Compliance efforts.

    GxP Approaches for Data Infrastructure and AI

    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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  • Image of life science manufacturing professional working on their quality management validation process on their laptop.

    Validation 4.0: How AI Is Transforming Life Sciences Quality Management

    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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  • Image of life sciences lab sales and quality professionals working together and looking at a computer screen.

    Uniting Sales and Quality in Life Sciences: A Recipe for Success

    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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  • MasterControl’s infographic “Your Guide to FDA Product Recall Avoidance"

    FDA Product Recall Avoidance: Your Guide to Preventing Regulatory Pitfalls

    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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  • Image of a pharma manufacturing technician working.

    Aligning Internal Procedures With ICH Guidelines: Challenges and Solutions for Pharma Manufacturers

    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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  • Image of a pharma manufacturing technician using a digital manufacturing software.

    From Error to Excellence: Why Pharma Manufacturers Need to Embrace Digital Maturity

    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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  • Life science manufacturing professional touching a digital QMS

    Elevate Your Life Sciences QMS: 5 Must-Have Features

    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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