The FDA's transition to the QMSR is creating a turning point for CDMOs in the medical device industry. Traditional quality systems can't keep pace with complexity, but AI offers a transformative solution. Discover how AI-powered quality management helps CDMOs navigate QMSR and ISO 13485 compliance and turn regulatory challenges into a competitive advantage.
Unlock physician trust! This blog post reveals how transparent data is now critical for pharma manufacturers. Beyond compliance, digital solutions transform operational insights into verifiable evidence of quality, building physician confidence and a competitive edge. Dive in to understand why data visibility is the ultimate trust imperative in the evolving health care landscape.
AI tools can transform life sciences training from a compliance burden to a performance driver. AI-powered solutions are standardizing knowledge, eliminating inconsistencies across global workforces, and leveraging advanced analytics to identify skill gaps. Discover the strategic imperative of AI for consistent quality and operational excellence.
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.
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.
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.
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.
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!
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.
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.
November 18, 2025
by Matt Lowe, Chief Strategy Officer, MasterControl
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.
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.
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.
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.
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
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.
October 29, 2025
by Katie Farley, VP Product, MasterControl
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.
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.
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.
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.
