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.
Juggling compliance training when everyone wears multiple hats? Discover practical approaches to managing regulatory-required training without overwhelming your small team. Learn how right-sized QMS solutions can transform compliance from headache to competitive advantage—even with limited resources.
Digital logbooks are empowering nutraceutical manufacturers to track every component throughout the supply chain and build unshakeable consumer trust. The result? Fewer disruptions, better compliance, and a competitive edge. In this blog post, you’ll learn how electronic logbooks can transform your operations.
For emerging life sciences companies, validation isn't just a checkbox—it's a mountain that can delay your product launch by months. When every resource counts, traditional validation approaches consume precious time your team simply doesn't have. This blog post reveals how innovative companies are slashing validation effort by an astonishing 80%-90% using modern, risk-based approaches supported by today's regulatory environment. Discover the modern approach that puts quality acceleration within reach.
Discover why 70% of manufacturers cite data quality problems as their biggest obstacle to AI implementation and how this particularly impacts contract manufacturers juggling multiple client products simultaneously. This blog post reveals the hidden costs of disconnected ERP, MES, and QMS systems in contract manufacturing, where information silos create cascading inefficiencies that directly affect client satisfaction and retention. Learn how forward-thinking CDMOs are gaining advantages through integrated systems that deliver real-time production intelligence, reduced review times, and enhanced client communication.
Life science manufacturers are drowning in paperwork while competitors go digital. Discover how leading CDMOs achieved 70% documentation efficiency gains without massive system overhauls. Learn the practical steps transforming contract manufacturing today.
Small life sciences startups face the same FDA regulatory scrutiny as industry giants, but without dedicated quality teams, which creates significant audit anxiety. With proper preparation focused on control, consistency, and commitment to quality, even the smallest life sciences companies can face FDA inspections with confidence rather than panic. Learn practical strategies that will help your smaller company build audit-ready quality systems.
Breaking language barriers just became easier for global life sciences companies. Discover how AI-powered document translation, summarization, and exam generation can save your team 330+ hours annually while ensuring consistent quality worldwide. No more compliance gaps from translation errors—just seamless global operations that keep everyone on the same page.
June 17, 2025
By Nicole Sherman, Senior Product Marketing Manager, MasterControl
Discover why leading life sciences executives unanimously agree that AI has evolved from a "nice-to-have" to a strategic imperative that will determine which companies thrive in the coming years. Gain exclusive insights from industry leaders who share five critical factors for successful AI implementation—from establishing effective governance frameworks to transforming workforce capabilities. Whether your organization is just beginning its AI journey or looking to accelerate adoption, these field-tested perspectives offer valuable guidance for navigating the opportunities and challenges of this revolutionary technology in a heavily regulated industry.
MasterControl has achieved FedRAMP Moderate authorization for its Quality Excellence Gov solution, becoming the first industry-leading QMS provider to meet this rigorous federal security standard. This milestone not only opens doors for government agencies and contractors but also delivers enhanced security benefits to all MasterControl customers through improved vulnerability management, stronger encryption, and real-time compliance monitoring. Discover how MasterControl's commitment to security excellence is helping organizations bring life-changing products to more people sooner while maintaining the highest level of data protection.
When handling sensitive information for multiple clients, security matters. Electronic logbooks provide fine-tuned access control that paper simply can't match. With digital logbooks, life sciences companies can build client confidence through better data security and compliance. Read how leading CMOs are protecting proprietary information while streamlining operations in our newest blog post.
June 11, 2025
by Manoj Dobbali, Manager, Machine Learning Ops, MasterControl
Step inside MasterControl's AI infrastructure with an exclusive look at GRID, our proprietary platform that abstracts the complexity of deploying large language models across diverse clouds, GPUs, and inference runtimes. This layered architecture separates concerns between model developers and MLOps, enables runtime-agnostic deployment, and delivers consistent observability across all AI applications. Find out how GRID is empowering our teams to iterate faster, deploy reliably, and scale intelligently across any environment.
With FDA warning letters highlighting CAPA deficiencies as a persistent quality management blind spot, life sciences companies face the impossible challenge of maintaining compliance with shrinking resources. Discover a seven-step methodology that transforms rigid CAPA processes into flexible frameworks that adapt to your unique needs—not the other way around. Learn how to turn quality management from a regulatory burden into your competitive advantage, even when resources are stretched thin.
In life sciences, 91% of professionals struggle with AI regulatory compliance. Navigating this maze doesn't have to delay innovation. Discover the five critical requirements for implementing AI in quality manufacturing while maintaining regulatory standing. Stop waiting and start transforming—your competitors already are. Get the compliance framework you need today.
AI isn't just changing compliance—it's revolutionizing how breakthroughs are delivered to patients. While only 9% of life sciences professionals understand AI regulations, purpose-built solutions are reducing time to market by 30%-50% without sacrificing compliance. Discover the five critical requirements for AI implementation that transform quality from bottleneck to innovation catalyst.
Small life science teams face unique document control challenges with limited resources. When SOPs scatter across systems and approval bottlenecks create compliance risks, quality suffers. MasterControl's startup decision guide reveals how to identify right-sized solutions for your documentation needs—from version control to 21 CFR Part 11 compliance—without enterprise-level budgets. Discover how to transform document management from regulatory burden to competitive advantage.
