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.
Discover how leading nutraceutical manufacturers are navigating industry trends while maintaining quality and compliance. From innovative delivery methods to sustainable packaging, learn how digital solutions are transforming manufacturing operations. This comprehensive guide explores key market trends and reveals how MasterControl's manufacturing software helps companies stay competitive in an evolving landscape. Plus, get exclusive insights from Nutrawise Health & Beauty's digital transformation journey.
The deepening attention to patient outcomes is reshaping how pharmaceutical and medical device companies approach product development, production, and delivery. This blog post explores how this patient-centric focus is driving innovation and improving health care outcomes.
January 29, 2025
by Anthony DeBiase, Director, Digital Process Development & Clinical Manufacturing, Continua Process Systems
Digital transformation provides an opportunity for life sciences manufacturers to streamline operations, ensure compliance, and maintain product quality. Discover how AI and other transformational technologies can augment core digital systems and how adopting digital systems empowers life sciences organizations to optimize production, enhance data integrity, and meet regulatory standards more efficiently.
FDA product recalls have increased 115% since 2018, posing significant risks to life sciences companies. This article explores the key factors driving recalls, their financial and reputational impact, and how implementing digital quality management solutions can help prevent them. Learn essential strategies for maintaining compliance and protecting your organization from costly recalls.
Artificial intelligence has emerged as a game-changing technology in various industries, and life sciences is no exception. This blog post explores how AI is reshaping life science quality management and why embracing this technology is essential for staying competitive in an evolving industry.
January 22, 2025
By Em Glassie, Partner and Director of Communication, L2Business Network
Quality can’t be inspected into a product; it must be designed into every key step. To help navigate this complex landscape, L2Business Network’s Em Glassie offers three compliance strategies every life sciences venture needs to succeed long term.
January 15, 2025
by Dustin Williams, ISO 17025 Consultant, Tech Engines
In pharmaceutical businesses whose processes rely on measuring equipment, the consistency and accuracy of measurement results is integral. Discover why the best way to reduce the risk involved with pharmaceutical equipment measurements is to make sure that the equipment is calibrated by an ISO 17025 accredited laboratory.
The digital disconnect rampant in life sciences manufacturing not only hampers efficiency but also introduces risks in a landscape where precision and compliance are paramount. Discover why the need for digital transformation in life science manufacturing goes beyond mere efficiency gains. Learn how your organization can overcome common challenges and achieve manufacturing excellence.
January 8, 2025
by Rebecca Waterbury, CEO, BatchWize and Kimberly Snyder, Executive VP Quality, Exemplar Compliance
Looking to optimize your pharma product release processes? The second installment of Batchwize’s two-part blog series on product releases focuses on strategies for effective planning, crucial QMS elements, setting appropriate product specifications, leveraging electronic systems, and the role of CMOs in the release process.
Product recall rates continue to rise – an alarming trend that underscores the urgent need for robust quality management processes in the life sciences industry. Discover how a comprehensive QMS can help your organization prevent quality issues that could lead to recalls.
December 18, 2024
by Rebecca Waterbury, CEO, BatchWize and Kimberly Snyder, Executive VP Quality, Exemplar Compliance
Part one of BatchWize’s two-part blog series covers the fundamental concepts of product release in pharma manufacturing, including its importance in ensuring drug safety and efficacy and the industry’s specific regulatory requirements. Learn about the data and records that are essential for a successful product release and discover why it's a comprehensive review process that entails far more than just signing off on executed batch records and SOPs.
Many life sciences organizations struggle to implement a comprehensive corrective action/preventive action (CAPA) system that satisfies both quality and regulatory requirements. Find out how optimizing CAPA processes helps companies improve overall product quality and safety while significantly reducing the risk of FDA observations and recalls.
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