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.
May 13, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Are you ready for an easier and more accurate way to manage logbooks? Find out why modern logbook software is much more than just “paper on glass” – it’s a revolution in production efficiency.
A recent MasterControl webinar explored how eQMS and EBR systems transform pharma quality management. The presenters examined how integrating eQMS and EBR data across systems helps companies achieve higher levels of digital maturity, giving them a competitive advantage through faster production and smarter decision-making. Discover how these digital tools boost efficiency, improve data integrity, and accelerate time-to-market.
May 8, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Contract manufacturers serve a vital role in the pharmaceutical industry, but it’s hard to select one that best fit your needs. Here are three tips for selecting pharma contract manufacturing partners that will help you achieve your business goals.
May 8, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Contract manufacturers in the pharma industry can count on one thing: the inevitability of supply chain disruptions. But reacting appropriately to destabilizing events requires a great deal of flexibility – a trait that’s difficult for most companies to develop. Learn three steps pharma CMOs and CDMOs can take to optimize supplier management by enhancing the flexibility of and visibility into their supply chains.
May 8, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
To maintain a competitive edge, companies in the life sciences are increasingly reliant on contract manufacturing partners. From the FDA’s perspective, these partnerships mean that both product owners and their contractors are responsible for cGMP compliance. Learn how CMO quality agreements help both parties uphold compliance.
May 1, 2024
By Becky Blankenship, Technical Writer, Cannon Quality Group
The cybersecurity of medical devices has never been more critical. Following these three key steps will help you ensure alignment with the FDA’s expectation for medical device cybersecurity compliance.
April 24, 2024
By Kathleen Brunner, President & CEO, Acumen Analytics
Generative AI is transforming the life sciences landscape and having a significant impact on GxP compliance efforts. In this blog post, Acumen Analytics CEO Kathleen Brunner examines the critical role AI is playing in redefining industry standards and changing the way companies approach compliance.
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