GxP Lifeline

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    EU to U.S. Market, Part 2: Strategic Audits for Expansion Into U.S. Medical Device Market

    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.

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    Harnessing the Power of Electronic Batch Records: bioMérieux’s EBR Journey

    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.

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    EU to U.S. Market: Understanding 3 Core Regulatory Contrasts

    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.

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    5 CAPA Best Practices for Life Sciences Manufacturers

    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.

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    New Paradigm for Quality Event Management Unveiled at Masters Summit

    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.

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    5 Ways to Eliminate the Hassles of Batch Records

    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.

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    Maximising Manufacturing Efficiency and Quality With Digital Work Instructions

    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).

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    How to Develop an Effective Supplier Scorecard

    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.

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    4 Digital Transformation Gaps in Pharma and Medtech Manufacturing

    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.

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    Digital Quality Management Is Hard - Here’s How To Do It Right

    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.

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    Paperless Manufacturing: How Toxic Is Your Relationship With Batch Records?

    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.

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  • Understand your relationship with quality audits by taking MasterControl’s quiz.

    Quiz: Do You Have a Quality Relationship With Your Auditor?

    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.

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    Insights Into APAC and Modern Manufacturing

    At MasterControl, we are broadening our gaze to the Asia-Pacific (APAC) region. Managing Director of APAC, Sara Bresee, weighs in on why modern manufacturing solutions are critical to APAC and around the globe. A digital system is what’s needed to be adaptable, meet regulatory requirements, and deliver the high level of quality your customers deserve.

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    5 Ways Digital Technology Will Transform the Supply Chain

    Digital transformation initiatives were already underway among life sciences manufacturers before COVID-19 struck, but the volatility around the global pandemic brought to light the importance of digital technologies in the supply chain. Research indicates that companies digitised many activities 20-25 times faster as a result of COVID-19. Integrating digital technologies in the supply chain has enormous implications for life science organisations.

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    How Electronic Batch Records and Device History Records Close the Digital Manufacturing Gap

    To support advanced data technologies and to compete in a modern market, manufacturers must close the digital gap on the shop floor, where critical production processes remain paper-based and disconnected. Digitizing the paper-based production record process can close this gap by creating productive connections between people, processes, and systems throughout the manufacturing process and across the entire enterprise for a holistic view of production data.

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    5 Ways Paper-Based Processes Hinder Financial Success

    If you haven't digitized yet, it's hurting the bottom line. As reported by Deloitte, digitally mature companies are, "about twice as likely as lower-maturity ones to report net profit margins an annual growth significantly above their industry average." Here's a look at five critical ways that paper-based processes are eating into revenue.

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    The Role of Supply Agreements in Life Sciences Manufacturing

    In light of the COVID-19 pandemic’s disruption to the global supply chain and the urgency around manufacturers quickly delivering life-saving products, it makes sense that manufacturing organisations and their supply partners might reassess their relationships and obligations to one another to manage the results of disruption to supply chain partners.

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    A Risk-Based Approach to Supplier and Vendor Audits

    A manufacturer’s ability to deliver high-quality products and maintain regulatory compliance relies in part on the quality-related activities of its own suppliers and vendors. Supplier and vendor audits can be important tools for manufacturing organisations to ensure their suppliers and vendors aren’t the source of major issues in product parts or materials. Digitisation can dramatically enhance supplier audits and vendor qualification audits in a number of ways.

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    Overview of the Medical Device Design History File, Technical File, and Design Dossier

    Medical device manufacturers must adhere to strict regulatory requirements, and the U.S. Food and Drug Administration’s 21 CFR Part 820 is a crucial set of regulatory guidelines meant to ensure the medical devices are high quality, safe, and effective. As part of these regulatory requirements, manufacturers must establish and maintain a medical device design history file (DHF) for each type of device. The following is an overview of the FDA’s design control and DHF expectations, as well as the role of the technical file/design dossier in European regulatory requirements.

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    Solving Quality Problems: Go Beyond Root Cause to ‘Real’ Cause

    Extrapolating the root cause of a quality problem isn’t the same as determining the problem’s real cause. Learn how to discern real causes and avoid the cycle of recurring root cause investigations.

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