Now that the QMSR makes 21 CFR Part 820/ISO 13485 harmonization official, medical device manufacturers stand to benefit in a variety of ways. This blog post examines the significance of the harmonization to industry stakeholders.
January 31, 2024
By Becky Blankenship, Technical Writer, Cannon Quality Group
Both the EU and U.S. markets are highly regulated, but there are important differences in medical device compliance that must be considered before taking the plunge. Cannon Quality Group examines three core regulatory contrasts that can make the difference in the success of your market entry.
As one of the largest manufacturers of collagen and turmeric in the U.S., Nutrawise Health & Beauty has dealt with numerous challenges involving paper logbooks. This post highlights the burdens the company has overcome by adopting logbook software.
Compliance with 21 CFR Part 11 is a big deal for life sciences companies. Failure to meet Part 11 requirements can result in serious consequences like product recalls and legal actions. Make sure all your regulatory bases are covered with this 21 CFR Part 11 compliance checklist.
January 18, 2024
By Ave Love, Staff Writer, MasterControl
Reduce the number of quality events and errors with these top 10 goals for the New Year. Learn about advanced quality event management (QEM) solutions to help you achieve continuous improvement for years to come.
January 11, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Wondering which manufacturing and quality topics your colleagues, competitors, and industry peers are most interested in? Check out this list of the top blog posts, reports, guides, industry briefs, and webinars viewed last year.
January 10, 2024
By Mitchell Hirsche, CEO, FojiSoft
The predictive analytics and quality control capabilities artificial intelligence provides help not only to anticipate disruptions but also to ensure products meet stringent quality standards. In this post, FojiSoft CEO Mitchell Hirsche highlights how AI facilitates pharmaceutical customization, improves supply chain logistics, and brings significant cost and environmental benefits.
January 9, 2024
By Ave Love, Staff Writer, MasterControl
With all the recent chatter, you may be wondering what generative AI means for pharma quality and manufacturing. This blog explores the differences between traditional and generative AI, points out some practical ways AI can enhance business processes, and how EU legislators are getting into “the AI Act.”
January 4, 2024
By Sarah Beale, Staff Writer, MasterControl
Internet of Medical Things (IoMT) technologies let physicians monitor patients remotely and collect more medical data faster than would be possible in any other way. However, just as with other connected devices, those in the medical sector need to be carefully controlled to ensure they remain secure.
January 3, 2024
By Al Swarts, Commercialization Strategist, SVA Life Sciences
Product supply management is often taken for granted in the life sciences. Find out why investing in product supply management improvements is in the best interest of all life sciences organizations, particularly emerging companies.
December 21, 2023
By Ryan Coughlin, Vice President, Enterey Life Sciences Consulting
In the ever-changing business landscape, effective change management is crucial for organizational success. Companies must implement a well-thought-out process that not only anticipates inevitable changes but also addresses them in a positive and proactive manner. Enterey’s Ryan Coughlin offers tips on continuous process improvement.
Outsourced Pharma and Life Science Leader announced the CDMO leadership awards earlier this year. Digitization in manufacturing – a critical component for CDMOs that want to be at the forefront of innovation in their industry – plays a major role for all the winners. See which MasterControl customers made the list.
December 14, 2023
By Lars Mouritsen, President & CEO, Avendium, LLC
Effective supplier management is a linchpin for success in dynamic industries where product quality and regulatory compliance are non-negotiable. In this blog post, Avendium CEO Lars Mouritsen outlines the nuanced strategies and key components necessary to ensure a seamless and reliable supply chain.
December 13, 2023
by Matt Lowe, Chief Strategy Officer, MasterControl
In highly regulated industries like food, drugs, and medical devices, manufacturing companies must make big investments in people and products so they can avoid costly and damaging recalls. Find out why product recalls have spiked significantly in the past few years and what that means for manufacturers and consumers alike.
December 7, 2023
By Sunny Mak, International Team, planeus
In highly regulated environments, the effectiveness of a medical device product plan is often ignored – to manufacturers’ detriment. Learn how modern digital tools give manufacturers the power to not only ensure their medical device product plans are transparent and efficient, but also traceable and compliant.
December 6, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
Effective corrective action/preventive action (CAPA) management isn’t just a regulatory requirement – it has a direct and measurable impact on product quality. If you want to optimize and simplify CAPA, these best practices provide the perfect starting point.
November 21, 2023
By Erika L. Roberts, MFS, Principal Consultant/Owner, ELR Lab Services LLC
Deviation management can be challenging – especially if your systems and processes aren’t connected. ELR Lab Services’ Erika Roberts offers a few tips on how to make managing deviations easier.
November 15, 2023
By Samantha Black, PhD, Head of Content, Elemental Machines
If you’re preparing to digitize manufacturing processes, the smartest approach is to learn from trailblazers’ experience. Read a recap of a conversation between Aspire Pharma’s VP of quality and Elemental Machines’ founder that shows how modern integrations are paving the way for comprehensive and transformative digital shifts in manufacturing.
November 8, 2023
By Steve Gompertz, Partner, QRx Partners
Process nonconformances often just seem to lead to longer, more prescriptive, and more complex documents. But longer and more complex doesn’t mean better. QRx Partners’ Steve Gompertz examines the many benefits that can be gained by taking a leaner, process-focused approach to documentation.
November 6, 2023
By James Jardine, GxP Lifeline Editor, MasterControl
This year’s World Quality Week, Nov. 6-10, offers the opportunity to realize your competitive potential. Join us in celebrating the masters of quality and sharing a few laughs about quality management professions.
