December 16, 2020
By Kathleen McHugh, Systems Lead Engineer, MPR Associates, Inc.
With the update to internationally recognized standard ISO 14971: Medical devices — Application of risk management to medical devices late in 2019, many manufacturers have taken a hard look at strengthening their post-production procedures over the past year to make improvements to how risk is managed throughout the entire product lifecycle.
December 15, 2020
By Quality Team Member, Cannon Quality Group
Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.
December 14, 2020
By Dale Thompson, Staff Writer, MasterControl
Every day, we use technology to make our lives easier. Similar technology is available to streamline manufacturing processes. It’s time to digitize and make production errorless, visible and connected.
December 10, 2020
By Sarah Beale, Staff Writer, MasterControl
All year we’ve been addressing connected quality data. Since we’re talking about connecting data across the organization, it makes sense that there would be advantages across the organization. Getting executive buy-in requires showing your C-suite how they’ll benefit from a digital transformation.
December 9, 2020
By Sarah Beale, Staff Writer, MasterControl
We recently sat down with North Pole CEO Kris Kringle to chat about how he took his operation from paper to digital. Turns out making presents for children all over the world requires a cutting-edge manufacturing solution.
December 3, 2020
By Steve Lynn, Executive VP of Pharmaceuticals
The U.S. Food and Drug Administration is changing their approach to audits. Understand how to prepare for a virtual inspection and how to ensure it goes smoothly.
November 18, 2020
By David Butcher, Staff Writer, MasterControl
Additive manufacturing (AM), often referred to as 3D printing, is frequently used for product research and development in many industries and for commercial production in some, including medical device manufacturing. In the medical device industry, it is expected to grow fast, offering significant value in the production of customized, fast-to-market devices.
November 17, 2020
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
Learn about the leading candidates in the race for safe and effective COVID-19 vaccines and therapeutics, as well as the technologies being utilized to shepherd us to the end of this pandemic.
November 12, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
World Quality Day 2020 provides the ideal opportunity to celebrate quality professionals who go above and beyond. It’s also a good time to have some LOLs about the quality world’s more comical and cringeworthy experiences. Giggle (or groan) along with the entries in the Quality Shorts Film Fest, and find out who won the 2020 Masters of Excellence Awards.
November 12, 2020
By Sarah Beale, Staff Writer, MasterControl
For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.
November 10, 2020
By Sarah Beale, Staff Writer, MasterControl
There’s no reason to keep living in the past when it comes to your batch review process. With review by exception, you can accelerate your processes to get product out the door faster. All while reducing frustration in both quality and manufacturing.
November 6, 2020
By Christine Park, Founder and Consultant, Christine Park & Associates
A robust, flexible quality management system (QMS) is a critical part of a business. Recent issues with COVID-19 illustrate why it is important than ever to integrate the QMS with the organization’s business continuity plan.
November 5, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
Software platforms are revolutionizing the quality function. What was once a guardrail for pharmaceutical and biotech companies is rapidly becoming a business accelerator that provides quantifiable competitive advantages. Discover how game-changing platforms are empowering leading companies to adapt to four predominant pharma industry trends by streamlining the management of data and quality processes.
November 3, 2020
By David Jensen, Staff Writer, MasterControl
With the fast-approaching Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), medical device manufacturers will be seeing more documentation requirements. One of the new documents is a summary of safety and clinical performance (SSCP). This is one of the annual reports manufacturers must provide throughout the life cycle of a device in order to remain compliant to sell products in the EU.
October 29, 2020
By Homi Dala, Consultant, Brandwood CKC
This article explores the definitive risk management standard for medical devices (ISO 14971) and the accompanying guidance on its application (ISO TR 24971) revised in December 2019. Although the basic foundation and structure of the risk management process has not changed from previous versions, revisions were undertaken to provide device manufactures with more clarity on critical aspects of risk management and hazard identification ensuring risk is effectively managed across all stages of the product lifecycle.
October 26, 2020
By David Jensen, Staff Writer, MasterControl
QuVa Pharma is a 503B compounding facility with a large catalog of medicines and a growing customer base. Read how the company has been improving its use of resources, efficiency and quality to keep up with increased production demands and tighter timelines.
October 21, 2020
By David Butcher, Staff Writer, MasterControl
Legacy technology can be a significant barrier to digital transformation. At Carestream Health, process manager Eli Tuber is leading a digital transformation of the company’s operational technology, from outdated legacy systems to modern digital platforms. The company is taking a platform approach to technology modernization, including electronic device history records (eDHRs), to transform manufacturing performance and quality.
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