July 23, 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.
July 23, 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 destabilising 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 optimise supplier management by enhancing the flexibility of and visibility into their supply chains.
July 23, 2024
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.
April 25, 2024
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.
March 28, 2024
by Becky Blankenship, Technical Writer, Cannon Quality Group
This blog post contributed by Cannon Quality Group 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.
February 27, 2024
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.
January 30, 2024
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
December 27, 2023
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 optimise and simplify CAPA, these best practices will help you get started.
November 16, 2023
by James Jardine, GxP Lifeline Editor, MasterControl
Quality professionals are all too familiar with having to fit their organisations’ processes to match the rigid functionality of their software systems. But those days are coming to an end. Find out how a revolutionary new tool is going to give quality leaders unprecedented control and forever change the way they manage quality events.
October 30, 2023
by David Jensen, Staff Writer, MasterControl
Digital manufacturing solutions, such as modern electronic batch records (EBRs), are key to optimising your entire manufacturing operation and production staff. This post addresses key aspects of a good digital manufacturing solution and offers tips on choosing the right system.
September 28, 2023
by James Jardine, GxP Lifeline Editor, MasterControl
Learn why it’s imperative for professionals in modern manufacturing environments to understand the value of digital work instructions, the increasingly important role of manufacturing work instruction software, and how these modern solutions fit into the broader manufacturing execution system (MES).
With manufacturers digitising at a rapid rate, understanding the core of the European Union’s (EU) guidelines, Annex 11, and its approximate FDA counterpart, 21 CFR Part 11, is more critical than ever. They are central to understanding the conditions for life sciences manufacturers’ electronic data in the EU and the U.S., and while the guidance is similar in both countries, it’s important to understand the key differences.
August 30, 2023
By David Butcher, Staff Writer, MasterControl
Supplier performance greatly affects the cost, quality, delivery, and responsiveness of a manufacturer’s business. For any life sciences manufacturer whose product quality relies in part on a supplier’s own product or service, the organisation must be able to ensure or improve high supplier performance. Discover why supplier scorecards are a logical place to start.
July 11, 2023
by David Jensen, Staff Writer, MasterControl
At MasterControl, we wanted to determine the extent of digital maturity at life sciences companies in their manufacturing production management processes. We gained valuable insight from a survey of 152 life sciences companies worldwide in pharmaceutical, biotech, biologics, and medical device manufacturing. Find out how your organisation can learn from the experience of others in overcoming production gaps.
June 15, 2023
Sarah Beale, Staff Writer, MasterControl
Digitising is a difficult process that involves every department in an organisation. At MasterControl, we conducted original research on where the life sciences industry stands in its QMS digitisation efforts and how we can help you make progress on your journey and overcome these difficulties.
May 30, 2023
by David Jensen, Staff Writer, MasterControl
It’s no secret that relationships can be complicated — even downright unhealthy. Figuring out where you stand and constantly having to decide your next course of action is exhausting. If you’re in life sciences manufacturing, you’re likely in an unhealthy relationship with paper batch records. Where is your relationship with paper headed? Take this quiz to find out.
May 17, 2023
by Sarah Beale, Staff Writer, MasterControl
Problematic quality processes can cause a rift between you and your auditor. If these issues aren’t addressed, you might find yourself dealing with the silent treatment. This quiz can tell you how things are going with your auditor.
April 11, 2023
by Dr. Ginette M. Collazo, CEO, Human Error Solutions
Human errors continue to plague pharma manufacturing environments because quality event investigations too often end where human error investigations should begin. Human Error Solutions CEO Dr. Ginette M. Collazo calls for a better understanding of human behaviour and explains why implementing adequate systems is the most effective way to control human error in manufacturing.
April 11, 2023
by David Jensen, Staff Writer, MasterControl
Since the launch of the Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR), there are fewer harmonised standards medical device companies can leverage to achieve and maintain compliance with these regulations. Read this article to learn about the current status of harmonised standards under EU MDR/IVDR and get tips on how to deal with the challenges of meeting the compliance requirements.
April 11, 2023
by James Jardine, GxP Lifeline Editor, MasterControl
More intelligent and more connected technologies are transforming the way life sciences companies manufacture and ensure the quality of their products. To gain a competitive edge, companies are leveraging innovative tools and new technology-enhanced approaches to quality management. Learn why using modern, connected solutions requires you to first understand the principles that form the foundation of successful Quality 4.0 initiatives.
