Although life sciences manufacturers face overwhelming challenges – especially those involving rapidly evolving technology, regulations, and consumer expectations – they must master four unchanging priorities: quality, compliance, resource management, and continuous improvement. MasterControl's Manufacturing Excellence (Mx) software solution transforms these challenges into opportunities through digitization, helping companies release products faster, ensure quality compliance, and adapt to market demands. Find out how leading companies like Dendreon maintain an impressive 99% right-first-time metric by making the leap from paper-based processes to a fully digitized manufacturing environment.
ThinkJSON represents a breakthrough in life sciences manufacturing, offering an AI solution that understands the unique language of GMP and transforms quality documentation with unprecedented accuracy. Discover how this intelligent solution can help life sciences companies overcome paper-based inefficiencies and transform their quality management systems without compromising on compliance or data integrity.
Discover how electronic logbooks are transforming pharmaceutical manufacturing by replacing error-prone paper records with cutting-edge digital solutions. This must-read piece reveals how embracing e-logbooks could give your organization the competitive edge it needs in today's demanding regulatory environments. Learn how digital logbooks are helping manufacturers maintain perfect records and protect patient safety while reducing operational costs.
April 9, 2025
by Viktoria Rojkova, Vice President of AI/ML and Data Science, MasterControl
Tired of time-consuming, error-prone paper processes in your life sciences manufacturing operations? MasterControl has developed ThinkJSON, a groundbreaking AI solution that can revolutionize how manufacturers digitize their batch records. Discover how this innovative technology combines advanced machine learning with industry-specific knowledge to create accurate, compliant digital records right the first time.
Modern lab operations demand more than spreadsheets and paper records. Discover how MasterControl Asset Excellence transforms lab asset management into a strategic advantage. Learn why leading laboratories are embracing digital solutions to ensure compliance, enhance data integrity, and free their teams to focus on innovation rather than documentation.
Contract manufacturers must embrace technology to adapt and thrive. Discover how leveraging advancements like AI-driven tools and cloud-based manufacturing solutions enables CMOs and CDMOs to achieve the agility, compliance, and operational excellence needed to successfully win clients and exceed sponsor expectations.
For startups and other small businesses in the life sciences, selecting the right quality management system (QMS) is a critical decision that impacts growth trajectory. Although immediate compliance needs may seem most pressing, learn why selecting a QMS that can scale as your company grows is equally important for long-term success.
March 26, 2025
by John Spanomanolis, Senior Principal QA Bio Medical Engineer Consultant, Foton Consulting
What's ahead for medical device regulations this year and beyond? From AI-powered devices to personalized medicine, regulatory bodies face unprecedented challenges in balancing innovation with patient safety. Discover key trends and solutions in this analysis from Foton on medical device regulatory challenges.
Looking for a quality management system (QMS) that will meet your startup’s needs today but can grow with you so you’re ready to face tomorrow’s challenges? Find out what the Quality Excellence Starter solution can do for your emerging life sciences organization.
March 21, 2025
By James Jardine, GxP Lifeline Editor, MasterControl
The transition from paper logs to electronic logbooks software doesn’t just represent an upgrade—it’s an evolution that’s necessary for ensuring operational excellence and maintaining the integrity of manufacturing data in an ultra-competitive life sciences industry. Get tips from the exclusive new Big Book of Logbooks and find out why more companies are ditching paper logs to boost efficiency.
Discover how AI is revolutionizing life sciences manufacturing and quality management. From automated document review to predictive analytics, AI is helping organizations eliminate trade-offs between quality, speed, and cost. Learn how industry leaders are leveraging AI-driven digital transformation to enhance compliance, reduce errors, and accelerate time to market. Get actionable insights and implementation strategies in this comprehensive guide to AI adoption in life sciences.
March 17, 2025
By James Jardine, GxP Lifeline Editor, MasterControl
In an unprecedented move signaling a major shift in life sciences manufacturing, MasterControl is launching its largest-ever marketing campaign to showcase Manufacturing Excellence (Mx), the fastest-growing manufacturing execution system (MES) software solution in life sciences. Learn the four reasons behind this unprecedented effort.
March 12, 2025
by Aron Yaeger, Principal Consultant & Quality Practice Area Leader, Enterey Life Sciences Consulting
Rather than waiting for the FDA to finalize a Quality Management Maturity (QMM) model, pharma organizations should adopt standardized QMM frameworks proactively, as they foster cross-functional quality ownership and provide many other benefits. In this post, Enterey explains why regular QMM self-assessments make good business sense. Learn how to develop a QMM approach that enforces quality standards, protects patients, and supports business success as regulations and expectations evolve throughout the product lifecycle.
Struggling with fragmented design reviews and ISO 13485 compliance? Discover how digital transformation is revolutionizing medical device quality management. Learn how leading organizations achieve 65% faster review cycles and 50% fewer documentation errors while maintaining FDA compliance. Get practical strategies for transitioning to a digital QMS and ensuring audit-ready design controls.
March 3, 2025
By James Jardine, GxP Lifeline Editor, MasterControl
MasterControl is acquiring computerized maintenance management software (CMMS) provider Qualer, which will extend MasterControl's ability to enhance life science product development by enabling organizations to manage quality, manufacturing, and asset performance within a single integrated platform. Find out what the enhanced manufacturing asset management capabilities can do for your organization.
It’s essential that organizations hoping to future-proof their operations understand the quality trends affecting the life sciences industry—from evolving regulations to the rising adoption of AI tools. Find out why turning these trends into opportunities for growth and improvement depends on having the right tools and strategies in place.
As life science manufacturing evolves in 2025, organizations face unprecedented changes in AI adoption, CDMO partnerships, and regulatory requirements. Discover how leading manufacturers are leveraging paperless manufacturing execution and digital transformation to increase efficiency by 35% and reduce time to market by up to four years. Learn which manufacturing trends will impact your organization's future success.
February 19, 2025
By Dan Petkanas, Global Alliances Director, Elemental Machines
Want to sleep better at night? Build data integrity into your systems from day one. Elemental Machines’ Dan Petkanas examines how validation checks, improved access controls, and comprehensive audit trails can protect your life sciences data and boost regulatory confidence.
The increasing demand for contract manufacturing services in the U.S. means CMO supply chain optimization is more critical than ever. While there isn't a one-size-fits-all approach, these three key steps can help life sciences companies realize the benefits of enhanced supply chain flexibility.
February 5, 2025
By Lars Mouritsen, President & CEO, Avendium, LLC
Internal audits are one of the most critical tools in assessing the performance of a life sciences company’s quality management system (QMS) and identifying areas for improvement. In this blog post, Avendium’s Lars Mouritsen examines the significance of internal audits, regulatory requirements that mandate their use, how often they should be performed, and how audit management software can streamline these processes.
