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.
April 17, 2024
By Melissa Leygan, Owner / Professional Software Admin & Training Consultant, eQMS Consulting LLC
Poor user adoption is often the biggest barrier companies face when implementing new software. If you’re implementing a new quality management system (QMS) solution, eQMS Consulting’s Melissa Leygan has five tips for encouraging user adoption.
April 11, 2024
By Renee VonBergen, Senior Product Manager, MasterControl
Artificial intelligence applications are taking the world by storm, but what are their practical applications in life sciences manufacturing? Read the results of MasterControl’s survey of more than 100 quality and manufacturing professionals who identified which AI tools would benefit them most.
April 4, 2024
By Jeff Sovis, President, Total eQMS Management
A modern eQMS solution has become an indispensable asset in life sciences manufacturing. Total eQMS Management’s Jeff Sovis outlines 10 features you should look for if you’re looking to implement new quality and compliance management software.
March 28, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
Want to make your quality processes more efficient? Discover how Navigate BioPharma has improved efficiency, simplified compliance, enhanced auditability, and boosted innovation by embracing digital quality management tools.
March 27, 2024
By Leah Jones, CEO, QA Connect Management Consulting, LLC
It’s not uncommon for medical device organizations to have bottlenecks with corrective actions/preventative actions (CAPAs). In this blog post, QA Connect CEO Leah Jones shares tips on streamlining CAPA management processes and improving root cause investigations.
March 20, 2024
By Becky Blankenship, Technical Writer, Cannon Quality Group
Part 2 in Cannon Quality Group’s blog series focuses on three ways manufacturers can leverage audits to streamline entry into the U.S. medical device market, avoid costly mistakes, and take advantage of this underused tool to ensure FDA compliance.
March 14, 2024
By James Jardine, GxP Lifeline Editor, MasterControl
The medical device industry serves a crucial role in improving patient lives, but navigating the complexities of regulatory compliance can be daunting. Discover resources that will give your quality and manufacturing teams the critical knowledge and practical strategies they need to tackle compliance challenges.
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.
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