Your clinical hold notice says “inadequate CMC information,” but the problem didn't start in submission documents. It started on the manufacturing floor, where documentation gaps, process drift, and undocumented changes create the regulatory deficiencies FDA flags. Discover where CGT manufacturing actually breaks down and get tips on bridging those gaps.
AI is reshaping life sciences quality management — and FDA compliance expectations are evolving right alongside it. Hear directly from an FDA policy specialist and MasterControl's VP of Data and AI on exactly what compliant AI adoption looks like in practice. Your roadmap to confident AI implementation starts here.
Is your lab one surprise audit away from utter chaos? Modern laboratory asset management goes far beyond tracking — it's about proving every instrument is compliant, calibrated, and fit for use before it touches a process. Discover what the new standard looks like and how improvements can transform your asset management practices.
Discover the four critical CGT manufacturing challenges slowing vein-to-vein timelines and learn how digital solutions are helping manufacturers break through operational bottlenecks.
The FDA's historic first warning letter for AI-related compliance missteps changes everything. Discover the critical mistakes that led to violations, new regulatory expectations, and how to implement AI safely in your life sciences operations.
Still drowning in quality event data? With the new Event Summarizer tool, you can use ISO 42001-certified AI to instantly transform complex event records into clear, actionable summaries—giving your team critical context in seconds, not hours. Find out how you can start making faster decisions, reducing cycle times, and helping patients sooner.
Despite massive digitization investments, 69% of pharma manufacturers can't move AI beyond pilot projects. Learn about new research that uncovers the connectivity crisis blocking intelligent operations—and how to solve it.
April 21, 2026
by Megan Haskins, Senior Customer Marketing Coordinator, MasterControl
Why start on paper when you can go digital from day one? See how OmniBuds' quality director leveraged 30 years of experience to launch a scalable QMS in 30 days, achieving 70%-75% throughput gains and reducing audit prep from weeks to 30 minutes.
April 16, 2026
By Caitlin Minton-Smith, Senior Product Marketing Manager, MasterControl
Cell and gene therapies account for 40% of all FDA clinical holds despite representing just 2% of trials. Most are driven by adverse events no system can prevent, but 21% are CMC failures that are almost entirely avoidable. This post explains the difference, and why it costs programs an average of 8.4 months.
Why can't you scale successful AI pilots? New research reveals 72% of medical device manufacturers are stuck in hybrid manual-digital operations. Learn about the connectivity crisis that’s likely blocking the scaling of your AI pilots and discover the three critical steps to overcome AI deployment challenges.
75% of CDMOs expect to get value from AI within three years, yet nearly 80% remain in preliminary phases. Discover the No. 1 barrier blocking deployment, where leading CDMOs focus their AI investments, and the strategic roadmap for transforming pilots into production-ready systems.
Not all AI vendors are created equal, and the wrong choice could worsen your integration challenges. Learn how to evaluate new AI-specialized vendors, enhance existing partnerships, and avoid costly mistakes. Get your complete vendor selection framework here.
50% of technology time is wasted on infrastructure issues, not innovation. Discover why integrated systems — the No. 1 AI prerequisite — are also the biggest barrier to deployment, based on insights from 300 life sciences professionals.
March 24, 2026
by Viktoria Rojkova, Vice President of AI/ML and Data Science, MasterControl, Bhavik Agarwal, Machine Learning Research Scientist, MasterControl, and Nidlhi Bendre, AI/ML Co-Op Intern, MasterControl
You shouldn’t have to choose between AI innovation and regulatory compliance. Learn how a deterministic approach can help you achieve 100% accuracy on critical manufacturing data while digitizing batch records in minutes. Discover how structured JSON transforms decades of paper documentation into actionable intelligence.
The talent pool for AI-proficient life sciences professionals is severely limited. Learn how to source, screen, interview, and retain quality candidates who can drive your digital transformation. This comprehensive hiring guide provides actionable strategies for every stage of the recruitment lifecycle.
March 10, 2026
by Matt Lowe, Chief Strategy Officer, MasterControl
Not all FedRAMP claims deliver true authorization. MasterControl CSO Matt Lowe examines the critical differences between FedRAMP Authorized solutions and "FedRAMP-adjacent" alternatives—and what this means for your agency's security and federal compliance.
MasterControl Manufacturing Excellence (Mx) ranked No. 7 on G2's 2026 Best ERP Software list—recognition earned through verified customer reviews. Discover why life sciences manufacturers choose Mx to eliminate production errors, accelerate time to market by 70%, and deliver seamless ERP integration.
Struggling with manual compliance processes? Discover how AI-enhanced quality management systems are helping pharma manufacturers achieve 100% FDA and ISO compliance—without disrupting operations or breaking budgets. Learn practical strategies for transforming compliance from burden to competitive advantage.
The focus has shifted from compliance to operational agility in medical device manufacturing. Four forces are reshaping the industry’s landscape: supply chain regionalization, digital thread mandates, embedded AI, and workforce transformation. Discover how leaders are turning industry changes into competitive advantages.
Digital compliance processes are now competitive differentiators for CDMOs striving to win sponsor contracts. Yet recent data reveals a surprising gap: only 27% of CDMOs have implemented electronic batch records. Discover what sponsors really want and the strategic moves that put contract manufacturing leaders ahead.
