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.
August 14, 2024
by Rebecca Waterbury, CEO, BatchWize
Thinking of implementing a new quality management system or electronic batch record solution? Batchwize CEO Rebecca Waterbury examines how the benefits can outweigh purchase and implementation costs and explains how experienced consultants can help you get the most bang for your buck.
Managing a diverse supplier network presents challenges like maintaining visibility, mitigating risks, and ensuring regulatory compliance. This blog post takes a closer look at these challenges and examines how a digital quality management system (QMS) can be a powerful tool to help medical device manufacturers overcome them.
August 7, 2024
By Sunny Mak, International Team, planeus
In medical device manufacturing, precision and efficiency aren't just buzzwords — they're essential for success. Yet many manufacturers are stumbling when it comes to a critical aspect of their operations: resource planning. In this blog post, planeus’ Sunny Mak offers proven, helpful manufacturing resource planning strategies.
July 31, 2024
By Em Glassie, Partner and Director of Communication, L2Business Network
Quality consistency begins where continuous improvement intersects with your quality management system. L2Business Network’s Em Glassie recommends these continuous improvement strategies for eliminating waste and improving product quality.
To maintain compliance and ensure product quality, it’s crucial for pharma companies to document deviations efficiently and effectively. Discover the deviation management improvements you can get from shifting from traditional paper-based systems to a digital quality management system.
The benefits of document control software solutions extend far beyond mere compliance. Learn how modern document control tools enhance overall operational efficiency, reduce errors, and simplify compliance.
July 16, 2024
By Greg Waldstreicher, Chief Executive Officer, Botable
AI chatbots can serve as information flow conductors, offering real-time assistance, streamlining processes, and ensuring regulatory adherence effortlessly. Botable CEO Greg Waldstreicher examines how companies can enhance GxP compliance, reduce human error, and foster a culture of continuous improvement by integrating AI chatbots into their quality management practices.
July 10, 2024
By Jaime Velez, Co-Founder, Operations & Quality Systems Improvement Experts (OQSIE)
While few organizations have been able to gain deeper visibility into their quality systems, many are overlooking a key path to more meaningful insights. OQSIE’s Jaime Velez examines the increasingly important role of document reviews and the potential they have to transform quality management processes.
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