Quality at the source isn't just a concept—it's the difference between life and death in cell and gene therapy manufacturing. With digital solutions slashing review times by 75% and cutting deviations by 25%, paper-based processes are becoming obsolete. Discover how modern CGT manufacturers are transforming quality from bottleneck to breakthrough.
Only 9% of life sciences pros understand AI regulations. That's a problem. MasterControl's Regulatory Chat bridges this gap with instant, AI-powered regulatory intelligence. No more document hunting. No more compliance headaches. Just smart, streamlined quality management that transforms SOPs, audits, and training.
Data integrity violations trigger 70% of FDA warning letters—and they’re often due to disconnected systems. By integrating your MES, QMS, and ERP platforms like SAP and NetSuite, you can eliminate paper-based inefficiencies, meet FDA requirements, and accelerate product releases. Discover how smart integration approaches can transform your operations, enhance data integrity, and keep you audit-ready.
For contract manufacturers, compliance isn't just a requirement—it's a dealmaker. Top CDMOs are leveraging digital maturity to transform regulatory readiness into competitive advantage. Discover how six evolving frameworks are reshaping sponsor expectations and why paperless operations aren't just about efficiency—they're your pathway to winning more contracts in an increasingly digital landscape.
With only 5%-10% of the needed manufacturing capacity available, cell and gene therapy (CGT) innovators face a critical challenge. Digital solutions can transform patient cells into life-saving treatments without sacrificing compliance or speed. Discover how your organization can eliminate paper, connect processes, and build quality into every step.
Eliminating 81% of manual data entries through automation isn't just a statistic—it's a revolution for life sciences manufacturers. Discover how smart automation strategies slash review times by 90%, increase throughput by 31%, and prevent millions of errors. Ready to transform paper-based frustration into digital manufacturing excellence? This is your roadmap to results that matter.
Traditional GMP approaches aren't built for the personalized medicine reality of cell and gene therapy development. With batch records spanning thousands of pages and 40% of executives doubting their scaling capabilities, digital transformation isn’t optional anymore—it's essential. Discover how leading manufacturers cut batch review time by 75% while strengthening compliance.
Quality managers face endless challenges with limited resources. As your life science company grows, those Excel spreadsheets become compliance risks. Pre-configured or fully customizable? Generic or purpose-built? Learn how to select the right QMS for your organization—one that balances immediate needs with future growth and transforms how you deliver life-changing products.
Are outdated documentation systems holding back your cutting-edge biotech manufacturing? Learn how biotech leaders are using electronic logbook software to prevent equipment downtime, enhance research collaboration, implement flawless sample tracking, and strengthen contamination controls—all while creating an unbreakable audit trail that satisfies the most stringent regulatory requirements.
Imagine cutting quality investigation cycles by 90%. Stop accepting months-long documentation bottlenecks as "just how pharma works." AI-enabled QMS technology is revolutionizing pharmaceutical SOPs, transforming quality from reactive to proactive, and freeing your team to focus on what truly matters—bringing life-changing products to market faster.
Environmental regulations are reshaping how life science CMOs and CDMOs compete for contracts, with ESG performance now a key differentiator. Learn how the shrewdest contract manufacturers are turning sustainability compliance from a burden to an advantage. Find out how digital solutions help eliminate paper waste while automating the documentation needed for both regulatory and ESG requirements.
Software purchase is just the beginning. While 85% of life sciences companies buy quality management system (QMS) solutions, only 29% fully implement them. Discover how to navigate hidden costs of validation, training, and data migration while maximizing ROI. Don't let implementation challenges derail your quality transformation—master them instead.
Still spending months on MES validation? Discover how industry leaders are slashing validation time by 80%—from months to just 45 minutes—while maintaining full compliance. Learn eight proven best practices and how the revolutionary, patented validation tools are transforming life sciences manufacturing with faster digital adoption, reduced costs, and improved regulatory compliance.
July 31, 2025
By Nicole Sherman, Senior Product Marketing Manager, MasterControl
Discover how leading life sciences companies are successfully implementing AI in quality and manufacturing operations, with real-world examples that have saved resources equivalent to 15 full-time employees monthly. This feedback from industry executives examines practical applications like automated complaint processing, predictive maintenance, and supply chain intelligence, while addressing industry-specific challenges like regulatory uncertainty and validation procedures. Learn how your organization can navigate the balance between innovation and compliance to gain significant advantages in operational efficiency, product quality, and regulatory readiness in this transformative era.
Say goodbye to $100K documentation errors and hello to 90% fewer mistakes. Discover how digital batch record solutions are helping life sciences manufacturers slash review times by 80% and achieve ROI in just four months. Ready to transform your manufacturing documentation nightmare into a competitive advantage?
Disconnected quality systems cost life sciences companies millions in rework, recalls, and missed opportunities. Discover how AI-enabled enterprise QMS solutions are delivering 90% faster investigations and 50% improved training cycles while keeping organizations perpetually audit-ready. Learn the six must-have features revolutionizing quality management in regulated environments.
July 23, 2025
by Alexander Kaplunov, Chief Technology Officer, MasterControl, and Viktoria Rojkova, Vice President of AI/ML and Data Science, MasterControl
As generative AI reshapes how we work, life sciences manufacturers face a critical dilemma: leverage these powerful tools without exposing proprietary formulations, manufacturing processes, and regulated data to third parties. How are industry leaders building compliant AI systems that protect intellectual property while still driving innovation? Learn practical strategies for implementing validated, audit-ready AI that satisfies regulators and safeguards your competitive advantage in an increasingly AI-powered landscape.
It’s no secret: paper batch records create compliance risks and inefficiencies in life sciences manufacturing. Discover five essential features of modern electronic batch record (EBR) solutions that streamline workflows, ensure data integrity, and accelerate product release in regulated environments. This blog post highlights how leading pharmaceutical, biotech, and medical device manufacturers are significantly reducing errors and costs while improving production metrics by implementing EBR technology.
July 17, 2025
by Jonathan LeBaron, Manager, Privacy and Compliance, MasterControl
MasterControl has achieved ISO 42001 certification for AI Management Systems, becoming one of the first companies in the industry to meet this international standard for responsible AI development. This milestone ensures life sciences manufacturers can confidently implement AI solutions that are transparent, accountable, and compliant while still driving innovation. Discover how MasterControl's certified AI governance framework provides the perfect balance of cutting-edge capabilities and risk mitigation for quality and manufacturing professionals in regulated environments.
In an era where drug-device combination products are revolutionizing patient care, contract manufacturers face unprecedented challenges. This blog post explores how CMOs can navigate the complex regulatory landscape, enhance supply chain visibility, and integrate quality processes to succeed in a market projected to reach $355.84 billion by 2034. Discover the critical strategies that forward-thinking manufacturers are implementing to compete in the rapidly evolving world of combination products.
