In today's fast-paced life sciences industry, EMEA manufacturers face unprecedented challenges: supply chain disruptions, evolving regulations, and unpredictable market demands. Yet many still rely on error-prone paper processes that delay product release and compromise compliance. Find out how modern EBR systems can transform batch record management from your biggest bottleneck to your greatest competitive advantage.
Forward-thinking life sciences companies in EMEA are reducing inspection risks while saving time and resources through intelligent audit automation. Discover how AI transforms EU life sciences audit readiness from an annual scramble to continuous compliance. These five strategies will show you how AI can be leveraged to strengthen documentation, predict quality events, and ensure data integrity across evolving regulatory landscapes.
In a world where inflation spikes and supply chain chaos have become the new normal, EMEA life sciences manufacturers face an impossible choice: adapt quickly or maintain rigid compliance? What if you could do both? Discover how industry leaders are transforming regulatory complexity into a strategic advantage by implementing configurable digital systems that cut master record revision time from months to just one week—without compromising standards.
In today's volatile landscape, EMEA life sciences manufacturers face an impossible choice: maintain rigid compliance or adapt quickly to market disruptions. But what if compliance and agility weren't competing priorities, but complementary strengths? Discover how forward-thinking manufacturers are leveraging modern digital solutions to transform manufacturing execution from a regulatory burden into a strategic advantage, creating operations that respond to change without compromising quality or compliance standards.
Version control across multiple languages is a compliance nightmare for life sciences manufacturers. But AI tools are now changing the game by automatically tracking and summarising document changes across versions and languages, providing the traceability regulators demand while reducing administrative burden. See how AI-powered document management is enhancing audit readiness across EMEA.
Is your CAPA process inspection-ready? EU GMP auditors are digging deeper than ever into quality documentation. Don't let inadequate CAPA records put your organisation at risk. Discover 7 essential strategies to strengthen your documentation and close the audit gap.
The deepening attention to patient outcomes is reshaping how pharmaceutical and medical device companies approach product development, production, and delivery. This blog post explores how this patient-centric focus is driving innovation and improving health care outcomes.
Artificial intelligence has emerged as a game-changing technology in various industries, and life sciences is no exception. This blog post explores how AI is reshaping life science quality management and why embracing this technology is essential for staying competitive in an evolving industry.
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.
