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.
Novel technologies are propelling manufacturers into a new era of digital record-keeping and fully connected facilities. Discover how modern electronic logbook software is enabling more accurate data capture, flexibility in log management, and seamless integration between key systems.
June 19, 2024
By Steven Lupo, Partner, Healthcare & Life Sciences, West Monroe
Artificial intelligence isn’t just a buzzword in life sciences manufacturing – it’s a promising new tool that’s optimizing quality control efforts. In this blog post, West Monroe partner Steven Lupo examines how AI is being used to increase inspection accuracy and extract new operations insights while reducing the cost of both.
Even though connecting QMS and MES breaks down data silos and drastically improves quality, manufacturers are slow to adopt of modern digital tools. A recent MasterControl webinar presented a strategy that bridges the digital gap and unlocks efficiency gains.
June 12, 2024
By Sridhar Iyengar, Founder and Chief Strategy & Technology Officer, Elemental Machines
The manufacturing world is shifting to a connected, automated future. In this blog post, Elemental Machines founder Sridhar Iyengar examines how internet of things (IoT) technology is helping to set new standards for integrated operations, driving significant ROI and compliance benefits for life sciences manufacturing companies.
June 6, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
FDA is expanding its oversight of laboratory developed tests. Find out when the changes are rolling out, what they’ll mean to you, and how to adapt to the new requirements.
If you think AI is just chatbots and language models, think again. FojiSoft CEO Mitchell Hirsche explains why there's a whole lot more to AI, and how it's going to change the manufacturing industry forever.
May 29, 2024
By Joe Jenkins, Vice President, Oberon Technologies
Training employees to perform complex processes is a challenge, especially when they’re working in regulated environments. Oberon Technologies VP Joe Jenkins explains why adding virtual reality (VR) training to your existing instructor-led and computer-based training programs can equip your organization to better handle ongoing workforce and GxP compliance training challenges.
May 21, 2024
By Ryan Coughlin, Vice President, Enterey Life Sciences Consulting
Today’s life sciences manufacturers can achieve simplicity – the ultimate sophistication – by implementing efficient and streamlined processes and coupling them with customized technological solutions. Enterey Vice President Ryan Coughlin recommends three steps to help organizations simplify complex processes.
May 15, 2024
By David Davis, President, DGD Solutions
A properly configured electronic quality management system (eQMS) can simplify compliance, improve record keeping, and make your company more competitive. So why do some companies still manage quality processes manually? DGD Solutions President David Davis examines the business case for making the leap to digital quality.
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