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.
Discover how effective communication between end-users and maintenance teams dramatically reduces downtime and boosts productivity in life sciences manufacturing environments. This blog explores the critical differences between work order requests and maintenance work orders, revealing how this knowledge can optimize your asset maintenance program and improve compliance.
Don't compromise on quality or compliance. Uncalibrated lab equipment threatens product integrity, regulatory standing, and patient safety. MasterControl's purpose-built equipment calibration software transforms this challenge into your competitive advantage. Discover how leading manufacturers are revolutionizing their approach to equipment management—and why you should too.
From comprehensive organizational views to asset-specific monitoring and service management, dashboards can eliminate information silos while providing the right insights to the right people at the right time. Discover how leading manufacturers are streamlining their analytics, enhancing regulatory readiness, and driving operational excellence with these powerful visualization tools.
Effective research laboratory management is essential for life sciences companies to maintain data integrity and regulatory compliance. Poor equipment management leads to inaccurate measurements, costly downtime, contamination risks, and safety hazards. Learn how modern lab management software solutions provide comprehensive asset tracking, preventative maintenance, and streamlined workflows that connect lab operations to quality systems—delivering the confidence needed to ensure product quality and pass regulatory inspections.
Effective lab equipment maintenance is more than routine upkeep—it's a strategic imperative for companies whose products are regulated. Learn how implementing preventive maintenance practices and a proper laboratory equipment management system creates operational efficiency, ensures compliance, and protects data integrity. Discover how MasterControl's solution transforms chaotic maintenance into streamlined, audit-ready operations.
For contract manufacturers, disconnected CAPA processes create quality nightmares that impact multiple clients. Discover how linking quality event identification, root cause investigation, and action implementation through a digital platform transforms reactive firefighting into strategic management. Learn the blueprint for CAPA success that's driving growth for forward-thinking CMOs.
Traditional "read and understood" training isn't cutting it anymore. AI tools allow you to transform compliance box-checking into real competency building. See how AI can boost investigation effectiveness by 30%-40% while addressing those frustrating audit findings around training gaps. Ready to change how your team learns?
Guardbanding ensures measurement accuracy by narrowing tolerance ranges to account for uncertainty. This article explores various guardbanding methods for life sciences manufacturers, from simple percentage-based approaches to advanced statistical techniques. Learn how MasterControl can simplify this complex process with intelligent automation that ensures compliance while reducing errors in your calibration management program.
Discover why accurate scale calibration is essential for life sciences manufacturers. Learn five key ways calibration can prevent quality failures, reduce waste, and facilitate regulatory compliance. Implement practical strategies to streamline calibration processes and safeguard data integrity with MasterControl's comprehensive quality management solutions.
Discover how health care asset management software transforms life sciences manufacturing—from extending equipment life and reducing costly downtime to ensuring regulatory compliance. Learn how modern asset management systems deliver better product quality, operational efficiency, and ultimately, improved patient outcomes.
