GxP Lifeline

 

Showing items tagged as eQMS

  • 5 Critical Factors in the CAPA Process

    March 2, 2021 By MasterControl

    Just as the name implies, corrective and preventive actions (CAPA) requires action. The key is knowing exactly what kind of action to take to solve the problem and prevent it from happening again.

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  • Making Sense of LIMS, QMS, GMP and Other ERP Acronyms for Life Sciences

    January 28, 2021 by Ralph Hess, Vice President, Navigator Business Solutions

    Acronyms can look more like alphabet soup, but here is your cheat sheet to understand some of the most common ones used in life sciences manufacturing: LIMS, QMS, GMP and ERP.

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  • Three Quality Management Trends to Watch in 2021

    December 15, 2020 By Richard Goeb, Quality Team Member, Cannon Quality Group

    Three key trends in MedTech quality management for 2021 include a rise in eQMS adoption, the continuation of remote audits and an increase in shared supplier audits.

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  • 5 Helpful Quality Event Management Tips From a CAPA Pro

    July 22, 2020 By James Jardine, Staff Writer, MasterControl

    Expert consultant, Ken Peterson, offers best practices for quality event management systems (QMS) that will help you avoid “death by CAPA.”

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  • Quality Control, Quality Assurance and the EQMS That Improves Both

    February 6, 2020 by Sarah Beale, Staff Writer, MasterControl

    Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Learn how both play into quality management and how an enterprise quality management system simplifies them.

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  • What Is a Quality Control System and How Can an EQMS Give it a Boost?

    April 16, 2019 by David Butcher, Staff Writer, MasterControl

    Life science and other companies doing business in FDA- and ISO-regulated environments understand how critical quality control and quality assurance are to successful quality management. “Quality control” and “quality assurance” are often used interchangeably when referring to activities conducted to ensure the quality of a product, service or process. Some quality control and quality assurance activities are interrelated, but the two are not necessarily interchangeable. Understanding the difference between the two quality processes is important, and a robust electronic quality management system (EQMS) will enable organizations to better manage both.

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  • Using Sherlock Holmes to Pick a Consultant

    January 23, 2019 by Sarah Beale, Staff Writer, MasterControl

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • 10 Key Steps for Implementing a QMS

    September 27, 2018 by Tifany Desprez, Communication & Marketing Manager with MasterControl Partner Apsalys

    Your company needs to an integrated, automated quality management system (QMS) to help you get your products to market faster and more efficiently. Where do you start? Consider these 10 steps to help you audit your current system and processes, get stakeholders onboard, and implement a QMS that will signifcantly improve your company's quality processes.

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  • Regulatory Barriers to Innovation for Startups

    July 31, 2018 by Tifany Desprez, Ph.D., Communication and Marketing Manager with MasterControl European Partner, Apsalys

    France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

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  • What the FDA’s New Ruling Means for Caffeine Supplements

    June 14, 2018 by Sarah Beale, Staff Writer, MasterControl

    Most of us need caffeine to get through the day, whether from coffee, soda or energy drinks. For those seeking alternate sources, nutraceutical companies have been happy to oblige. However, recent headlines about dangerous caffeine supplements and subsequent action by the FDA might be worrisome to consumers and manufacturers.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    May 31, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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  • GDPR Deadline Approaches: What Is Expected for Compliance?

    April 3, 2018 by Dave Jensen, Staff Writer, MasterControl

    First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).

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  • What Do Changes to Australia’s PIC/S Guide to GMP Mean for Pharma Down Under?

    February 1, 2018 by Luana Carone, Solutions Consultant for Australia/New Zealand, MasterControl

    It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.

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  • 4 Ways an EQMS Can Help You Improve Supplier Visibility

    January 9, 2018 by David Butcher, Staff Writer

    Leveraging a centralized electronic quality management system (EQMS) can help medical device manufacturers bring together all quality data, leading to greater visibility and solutions to at least four key quality challenges across the extended supply chain, according to MasterControl Senior Product Manager Terrance Holbrook.

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  • 5 Most Common Pharma Form 483 Quagmires & How to Avoid Them

    December 26, 2017 by James Jardine, Staff Writer, MasterControl

    See the most common reasons the FDA cited pharmaceutical companies with Form 483 Inspectional Observations last year and examine potential remedies that can help prevent future warnings.

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  • 6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

    February 19, 2015 David R. Butcher, Marketing Communications, MasterControl

    An optimal quality management system (QMS) is the foundation for long-term regulatory compliance, especially for organizations working within strict U.S. Food and Drug Administration (FDA) and International Organization for Standardization (ISO) environments. Those lacking a solid quality infrastructure are simply not equipped to face the challenges of the regulatory environment and meet the demands of a competitive market.

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  • Basics: Documenting a Real QMS

    December 18, 2014 T. Dan Nelson, Consultant

    Using ISO  parlance, a management system is designed to achieve objectives.   In the case of a quality management system (QMS), the most basic objective is to succeed by satisfying customers.  A QMS is a system designed to satisfy customers by providing them with timely, quality products and services.

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  • What Is Driving More Organizations to Plan an EQMS Adoption?

    October 28, 2014 David R. Butcher, Marketing Communications, MasterControl

    In response to increased pressure to simultaneously meet compliance, mitigate risks and improve cost savings, a growing number of organizations are taking steps to transform their quality management by adopting enterprise quality management software (EQMS). Research indicates that approximately 40 percent of companies are currently planning to implement an EQMS solution. What are the key drivers behind the rising number of companies moving toward EQMS adoption?

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  • Why Do Corrective Actions Fail?

    September 23, 2014 Ed Grounds, President Integrated Solution Providers Software, Inc.

    Each year, the most popular learning course we provide is targeted at developing the skills necessary for our customers’ associates to implement their corrective action programs effectively and efficiently. Throughout the years, we have been asked the same question hundreds of times, “What are the most common reasons corrective actions fail?” Usually this question is asked during the corrective action learning session by a management team member hoping that we will deliver the message to the other team members that they are failing. Normally, we turn the question back around to the group and ask them why they think their corrective action program fails. The most common answers we hear are: limited time, resources, training, or not knowing which tools to use.

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  • Developing a QMS: Should You Buy or Build?

    December 11, 2012 Cindy Fazzi, Marketing Communications Specialist, MasterControl, Inc.

    When it comes to a quality management system, should you buy or build? Many regulated companies face this dilemma. Perhaps these companies are small startups without a QMS, or maybe they are established but they want to improve their existing systems.

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