GxP Lifeline
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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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    Comparing EU Annex 11 and 21 CFR Part 11

    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.

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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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    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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    How to Reduce Human Error on the Pharmaceutical Manufacturing Floor

    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.

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    Managing Harmonised Standards for EU MDR/IVDR Compliance

    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.

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    3 Characteristics of Successful Quality 4.0 Initiatives

    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.

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    How Modern MES Solutions Meet the Demands of Pharma Manufacturing

    Modern manufacturers are looking for flexible solutions to help them automate workflows and reduce errors. Legacy manufacturing systems are hard to come by. Find out what a modern manufacturing execution system (MES) can do that legacy systems can’t – and how soon you can implement one.

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