With a 115% increase in FDA recalls since 2018, it's clear that life sciences companies need to take proactive measures to protect their products, reputation, and bottom line. This blog post explores the causes of recalls, their impact on consumers and businesses, and how connected digital solutions can help you prevent them.
Selecting the right hardware to support QMS and MES software solutions is a critical step life sciences manufacturers often overlook. Since it’s easy to be overwhelmed by the variety of hardware options available, DTG CEO Stephen Shaheen examines how to simplify those choices using a targeted and systematic approach.
October 23, 2024
By Lars Mouritsen, President & CEO, Avendium, LLC
Nervous about changes to the regulation of laboratory-developed tests (LDTs)? This blog post provides an in-depth analysis of the FDA’s final rule, outlines the history and context of LDT regulation, and highlights the phases of implementation, challenges, and opportunities for laboratories and manufacturers.
October 15, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
When FDA investigators identify issues that could potentially lead to product recalls, they typically stem from quality failures like inadequate documentation, poor quality event management, and insufficient process validation. Find out how you can effectively address these vulnerabilities and significantly reduce the risk of an FDA recall.
October 9, 2024
by Nathan Clark, Founder & CEO, Ganymede
This blog post shares some of the challenges, opportunities, and best practices for building a robust data platform that will enable AI in a way that supports GxP compliance. Discover why it comes down to data availability and infrastructure to ensure that your models are reliable, secure, and easily accessible for regulatory scrutiny.
October 3, 2024
by Philip Jarvis, Director of CQV and Digital Validation Strategy, VEQTOR and Peter Gordon, Digital Innovation and Technology Lead, VEQTOR
All the buzz around AI has life sciences companies wondering how emerging technologies can be applied to advance validation processes and improve quality management. VEQTOR’s team examines ways generative AI can be put to work to make real-time verification and seamless integration with digital ecosystems possible.
October 2, 2024
By Christina Pecoraro, Owner/Founder, Lotus Business Solutions LLC
The relationship between quality and sales team is not only crucial, but it can transform a company and drive unprecedented successes. Lotus Business Solutions’ Christina Pecoraro examines how this relationship can result in more positive customer experiences and company growth.
October 1, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
With FDA product recalls on the rise, life sciences companies need help navigating the intricacies of regulatory compliance and quality management. This blog post provides recommendations to help manufacturing and quality professionals effectively manage product quality issues, avoid receiving FDA Form 483 observations, and proactively prevent recalls.
Navigating ICH guidelines presents significant challenges for pharmaceutical manufacturers. This blog post explores the key difficulties in interpreting guidelines, adapting existing systems, and ensuring consistent application across departments. It offers practical solutions, emphasizing the role of modern pharma QMS software in overcoming these hurdles. Discover how leveraging technology can streamline compliance efforts, drive operational efficiency, and improve product quality.
September 24, 2024
By Dan Petkanas, Global Alliances Director, Elemental Machines
As quality and compliance standards in pharma become higher and stricter, the shift from error-prone manual processes to operationally robust, fully digitalized processes can no longer be considered optional. Elemental Machines’ Dan Petkanas explains why it’s critical for pharma manufacturers to embrace digital maturity.
As life sciences companies grow and evolve, their quality management systems (QMS) must keep pace. A QMS that was once good enough to get the job done might now be hindering your operations. Learn the five signs indicating it's time for a QMS upgrade.
September 17, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
The fallout from FDA recalls can be profound, leading to massive financial losses, reputation damage, and even legal consequences. Find out what the new “Ultimate Guide to FDA Product Recalls” says about the upstream impact of recalls and how life sciences companies can prevent them.
Discover how investing in a pharma MES can significantly improve your ROI by streamlining cGMP compliance efforts and minimizing hidden costs. Learn about the benefits of automating key processes, reducing errors, and streamlining audits. Download our free Manufacturing Software Buyer's Guide to learn more and start exploring how MasterControl MES can transform your operations.
September 11, 2024
By Renee VonBergen, Senior Product Manager, MasterControl
Generative artificial intelligence (AI) tools aren’t intended to replace humans. Rather, they’re designed to assist and augment them. Learn the benefits of taking a collaborative approach to using AI and how modern tools like MasterControl’s Exam Generator let humans actively guide and refine AI output.
A new MasterControl survey report on FDA product recalls highlights the disconnect between consumer awareness and action, how recalls erode trust in life sciences manufacturing processes, generational differences in recall responses, and strategies for rebuilding trust. Take a deep dive into the report’s examination of the long-term impacts of recalls and learn why effective product recall management is essential for companies to maintain consumer trust and protect brand reputation.
Nothing is more important to manufacturers in the life sciences than ensuring product quality. Learn how integrating QMS and MES in a single platform helps life science manufacturing organizations improve product quality, achieve greater efficiency, and accelerate regulatory compliance.
September 4, 2024
By Becky Blankenship, Technical Writer, Cannon Quality Group
Many medical device companies are wondering how the FDA’s Quality Management System Regulation harmonization will impact their quality management systems. No matter the complexity of your QMS or medical device, here are three simple steps device manufacturers should take to simplify the transition to the QMSR.
August 28, 2024
By Edwin Chung, Vice President of Service Delivery, SPK and Associates
How can medical device companies evolve and grow in the increasingly complex world of compliance and technology? Find out how Veranex overcame regulatory and efficiency challenges by implementing an advanced quality management system.
Managing risk is challenging in the evolving pharma landscape. Discover how a proven quality management system can help pharmaceutical companies overcome common risk management challenges and achieve operational excellence.
August 21, 2024
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences, and Michael Bradley, Lead Validation Specialist, AVS Life Sciences
In their industry experience, AVS Life Sciences experts see six common barriers that companies face in their software validation efforts. In this blog post they offer tips on making validation less challenging, overwhelming, and time-consuming.
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