March 5, 2024
By Michael Roberts, Vice President, SPK and Associates
GxP compliance in software development processes improves data safeguarding and promotes trust. In this post, SPK and Associates Vice President Michael Roberts examines how DevOps in life sciences manufacturing facilitates GxP compliance, innovation acceleration, and superior software quality.
February 28, 2024
By Lisa Helmonds, VP, Quality & Operations, AVS Life Sciences
Electronic batch records (EBRs) can save you tons of time and eliminate frustration in reviews. Learn how you can reclaim time so you can focus on truly resolving quality issues instead of chasing paper.
February 27, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Paper batch records are a threat to data integrity and efficiency in life sciences manufacturing. If you're considering making the change to electronic batch records, bioMérieux's experience offers valuable insight into the selection process, implementation strategies, and the long-term benefits of modern EBR software.
February 21, 2024
by Dr. David Orr, CEO, Medpoint, LLC
Finding out the costs of nonconformance can help you improve, prevent future problems, and save money. In this blog post, Medpoint CEO Dr. David Orr examines different ways to measure nonconformance costs, including using nonconformance management software and having a good quality management system (QMS).
February 15, 2024
by James Jardine, GxP Lifeline Editor, MasterControl
Are you overwhelmed by all the FDA and ISO regulatory requirements pharma companies must meet? If your organization faces the common types of FDA and ISO compliance management challenges covered in this blog, it’s time to implement a pharmaceutical compliance software solution that can help you overcome them.
February 14, 2024
By Ryan Coughlin, Vice President, Enterey Life Sciences Consulting
As manufacturing operations evolve, there’s an increasing need for more efficient document management. Enterey’s Ryan Coughlin examines how life sciences manufacturers can turn document chaos into document control.
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 Matthew M. Lowe, Chief Product & Marketing 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.
