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GxP Lifeline
  • Understanding GMP certification in CGT manufacturing

    Navigating the M&A Landscape in Cell and Gene Therapy: What Manufacturers Need to Know

    The CGT M&A landscape is booming, but manufacturing readiness is now key to valuation. Discover why digital maturity, robust CGT manufacturing, and advanced cell therapy software, including MES for cell and gene therapy, are critical for attracting acquirers. Uncover the challenges and competitive advantages in this blog post – your essential guide to maximizing M&A appeal.

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  • Navigating government shutdowns in life sciences manufacturing

    How Large-Scale Life Sciences Manufacturers Can Navigate Government Shutdown Disruptions

    Government shutdowns pose immense risks for enterprise life sciences, from escalating documentation errors to fragmented systems. Discover how large enterprises can fortify operations against these disruptions. Learn strategies for navigating regulatory uncertainty, ensuring compliance, and maintaining operational continuity with robust enterprise solutions.

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  • Using AI powered systems during visual inspections for life science quality and manufacturing

    Modernizing Quality Control With AI-Powered Visual Inspection: A New Era of Precision

    Revolutionize quality control with AI-powered visual inspection. Discover how regulated industries are overcoming manual limitations to achieve near-perfect accuracy (up to 99.86%). Take a closer look at AI's transformative impact on quality management, its integration with MES, and how MasterControl solutions empower a smarter, compliant manufacturing future.

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  • How manufacturing software is transforming quality and trust for pharmaceutical industry

    The Digital Backbone: How Pharma Manufacturing Software Is Transforming Quality and Trust

    With 81% of physicians questioning drug quality, discover how digital manufacturing platforms are rebuilding trust by enabling transparency, reducing errors, and ensuring consistency. Learn how connected systems slash batch release times from months to days while delivering the manufacturing excellence physicians demand before confidently prescribing medications to their patients.

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  • Image of lab professional using lab asset management software.

    Risk-Based Quality Management in the Modern Laboratory: Digital Tools for ISO 15189 Compliance

    Struggling with ISO 15189 compliance and manual quality systems? Discover how risk-based quality management, powered by MasterControl's digital tools, transforms life sciences labs. Learn to streamline nonconformance, boost efficiency, and achieve robust compliance with advanced lab management software. Ready to revolutionize your quality processes? Read the full article for practical guidance!

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  • Understanding how modern pharma manufacturing improves physician trust

    Bridging the Trust Gap: How Modern Pharma Manufacturing Systems Impact Physician Confidence

    Discover why 81% of physicians question medication quality and how that mistrust is tied directly to your manufacturing processes. Our research reveals the three digital pillars transforming physician trust: connected quality systems, electronic batch records, and specialized AI. Learn how manufacturing excellence rebuilds confidence and drives prescribing behavior.

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  • Understanding Quality Culture Best Practices in Biomanufacturing

    Leveraging AI in Life Sciences Contract Manufacturing: A Path to Enhanced Efficiency and Compliance

    Artificial intelligence isn't just enhancing life sciences contract manufacturing—it's completely reimagining it. When manufacturers embrace AI, they don't just improve efficiency—they revolutionize how quality and compliance happen. The numbers speak volumes: $100 billion in potential value. Investigations that are 30%-40% more effective. But this isn't about statistics—it's about helping you create life-changing products faster and with more confidence.

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  • Understanding Quality Culture Best Practices in Biomanufacturing

    Advancing Quality Culture in Biomanufacturing: Best Practices

    MasterControl CSO Matt Lowe examines how technology plays a critical role in advancing quality culture within the biomanufacturing industry, from overcoming implementation challenges to enhancing operational excellence. Learn how AI-powered tools and purpose-built software solutions can support the three pillars of quality culture: leadership commitment, employee ownership, and continuous improvement.

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  • Understanding GMP certification in CGT manufacturing

    Navigating the CGT Frontier: Seamlessly Transitioning From Development to Commercial Manufacturing

    Ready to revolutionize your CGT manufacturing? Discover how standardization, digitalization, and integration can overcome capacity challenges and accelerate your journey from development to commercial scale. Learn the three game-changing strategies helping manufacturers deliver life-saving therapies to patients faster.

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  • Thermo Fisher Scientific QMS Case Study

    Enterprise QMS: Eliminating the $100,000 Documentation Error

    Paper-based documentation in life sciences manufacturing leads to costly errors, regulatory issues, and delayed product delivery to patients. Discover how leading companies implementing digital enterprise QMS solutions have achieved millions in savings and reclaimed thousands of hours from administrative tasks through digital transformation. This blog post provides a practical framework for assessing digital quality readiness and implementing enterprise-wide solutions that connect quality management with manufacturing excellence.

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  • Advantages of modernizing labs in life sciences

    Data-Driven Quality: How Lab Modernization Creates Competitive Advantage in Life Sciences

    Discover how integrating lab asset management with quality systems creates data-driven operations that reduce deviations, accelerate investigations, and ensure compliance—positioning your lab for competitive advantage in today's fast-moving life sciences landscape.

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  • Understanding FDA CSA Guidelines for Manufacturing

    FDA Finalizes Computer Software Assurance Guidelines: What This Means for Life Sciences Quality Manufacturers

    The FDA's Computer Software Assurance guidelines are here, and they change everything. Traditional validation is out. Risk-based thinking is in. Slash validation time from months to minutes. Focus on what matters, not what doesn't. Embrace digital transformation without drowning in documentation. Ready to validate smarter, not harder? Your customers and patients are waiting

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  • Using AI-driven document management to optimize processes

    From Inbox Overload to AI Assistance: How Document Management AI is Transforming Quality Teams' Daily Work

    Drowning in document chaos? Quality teams spend 9+ hours weekly hunting for files while FDA citations skyrocket. Discover how AI is transforming document nightmare into strategic advantage, saving 800+ hours annually. No more inbox overload or compliance panic—just intelligent automation that works. That changes everything. Read how.

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  • Embracing risk-based CSA in MES

    Risk-Based Assurance in Pharma Manufacturing: Balancing Compliance and Operational Efficiency in MES

    Discover how the shift from traditional CSV to risk-based CSA approaches is transforming validation processes in pharma manufacturing. Learn how modern MES validation strategies can reduce validation time from months to minutes without jeopardizing compliance. This innovative approach isn't just a regulatory trend—it's becoming a competitive necessity for manufacturers seeking operational efficiency. Find out why.

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  • Understanding GMP certification in CGT manufacturing

    Risk-Based Approaches to CGT Clinical Trials Under E6(R3): A New Path Forward

    When every minute counts in CGT clinical trials, traditional approaches fall short. E6(R3) changes everything. Discover strategies that will keep your CGT clinical trials compliant and focused on what matters most—getting life-saving therapies to patients right the first time, right on time. Find out how digital platforms cut batch review time by 75%, slash data integrity errors by 90%, and transform quality from bottleneck to breakthrough.

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  • Image of a life science manufacturer touching a digital screen.

    Beyond the Specialists: Building a Culture of Compliance Through Accessible Regulatory Knowledge in Medical Devices

    A shocking 91% of life sciences professionals can't fully navigate U.S. and EU regulations. Why wait for overwhelmed specialists when AI can democratize regulatory knowledge? Discover how instant regulatory intelligence eliminates bottlenecks, empowers teams, and transforms compliance from burden to competitive advantage.

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  • Image of medical device professionals performing a design review using a digital QMS.

    Connect Your DHF to the Manufacturing Floor: Watch Quality Soar

    Are your DHFs disconnected from production because your processes are still paper-based? Why trade quality for speed when you could have both? Learn how a modern digital solution collects, connects, and contextualizes production data—creating a closed-loop quality system that eliminates errors and accelerates product release. Get higher throughput with lower scrap rates and zero paper.

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  • Image of a life science contract manufacturer working on a digital tablet.

    Flexible Manufacturing: How to Build Agility Into Your Life Science CDMO Operations

    Contract manufacturers in the life sciences face unprecedented complexity. Learn how CDMOs can transform operations for agility, speed and quality—mastering multi-product facilities and rapid changeovers while maintaining compliance in high-mix environments.

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  • Digitization through quality and manufacturing integrations

    Bridging the Digital Divide in Life Sciences Enterprise Manufacturing: Connecting Production and Quality Systems

    The digital divide between systems is costing you 70% of your manufacturing lead time. When ERP, MES, LIMS, and QMS systems can't talk to each other, operators become data entry clerks and errors multiply. See how leading manufacturers are connecting these systems to achieve 75% faster batch release and 90% fewer errors.

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  • Understanding GMP certification in CGT manufacturing

    ICH E6(R3) in Effect: Transforming Quality Management for Cell and Gene Therapy Trials

    ICH E6(R3) is here, and it's game-changing for cell and gene therapy developers. With only 5%-10% of needed manufacturing capacity available, this principle-based guidance emphasizes risk management and digital tools that align perfectly with modern CGT operations. Companies implementing these approaches are seeing 75%-80% faster batch releases and 90% fewer errors. Find out why that changes everything.

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