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Showing items tagged as Quality and Compliance

  • Effective Nonconformance Management Key to FDA and ISO Compliance

    December 22, 2020 By Jason Clegg, Marketing Strategy Director, MasterControl

    It’s impossible to avoid occasional nonconforming products and materials. But what’s most important for manufacturers of regulated products is how nonconformances are managed. Learn how to handle nonconformance challenges, avoid warning letters and maintain alignment with FDA and ISO requirements.

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  • Trend Analysis: Making the Most of Meaningful Quality Data

    November 13, 2020 By James Jardine, Staff Writer

    Trend analysis in quality management is particularly useful for monitoring process changes that can yield substantial process improvements. Learn how advanced digital tools can supercharge your trend analysis capabilities by providing access to real-time, connected quality data.

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  • Quality Audit—A Tool for Continuous Improvement and Compliance

    September 4, 2020 By Jason Clegg, Director, Marketing Strategy

    Audits are essential to regulated industries. The type of audit, who conducts it, and which regulations and standards are involved are all important. The process has its own challenges which have only been exacerbated in the current environment.

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  • Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    August 20, 2020 David Butcher, Staff Writer

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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  • How to Shift From Proactive to Predictive Quality Data Management

    August 11, 2020 by James Jardine, Staff Writer

    The reluctance to abandon conventional paper-based quality management systems (QMS) has long typified the life sciences industry’s approach to quality. Familiar yet inefficient quality models are shortsighted, however.

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  • Software as a Medical Device – Upcoming Changes to the Australian Regulations

    July 17, 2020 by Belinda Dowsett, Quality Assurance Manager and Consultant

    So much can change over a nearly 20 year period. Since the Australian Regulatory Framework for medical devices was adopted in 2002, the use and accessibility of software in medical applications has advanced beyond expectation.

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  • 5 Essentials to Effectively Manage a Quality System

    March 19, 2020 by Brian Matye, CFO, Regulatory Compliance Associates Inc.

    In the life sciences and other regulated industries, effective quality system management is essential. Companies can’t deliver a safe and effective product and comply with regulators without one. But it’s also crucial that companies take a risk-based approach to selecting and developing a quality system that's well suited to their needs. Digital QMS solutions often offer unsurpassed benefits that a paper-based system can’t deliver.

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  • The FDA Mulls Proposed Ratings to Measure Drugmakers’ Manufacturing Quality

    December 11, 2019 by Mike Rigert, Staff Writer, MasterControl

    A recent U.S. Food and Drug Administration (FDA) report indicates one of the reasons for drug shortages in the U.S. is the absence of incentives for manufacturers’ facilities to go beyond minimal quality compliance. A proposed voluntary FDA ratings system based on objective criteria could potentially benefit and reward drugmakers for their facilities’ heightened quality manufacturing maturity.

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  • 2019 Med Device Trends to Watch For: Regulatory Changes

    February 14, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

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  • Quality Assurance and Quality Control: What's the Difference When It Comes to Managing Quality?

    November 13, 2018 by Kimberlee A. Washburn, Regulatory Affairs Author

    Quality assurance and quality control functions in the manufacturing process may share some similarities but they’re actually quite different animals. Learn about the purpose of each and their relationship to each other in enabling life sciences and other regulated manufacturers to maintain a high level of quality and compliance for their products.

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  • Advancing the Case for Quality in Medical Device Manufacturing

    October 18, 2018 by Stephanie Christopher, Program Director, Medical Device Innovation Consortium

    We all seek quality in goods and services, but how can that quality be assured? The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH), as part of its Case for Quality initiative, last year launched the Voluntary Medical Device Manufacturing Product Quality pilot program based on a maturity model as an alternative to the traditional path of a routine FDA inspection. Find out if the program might be the right step to boost your company’s quality and compliance.

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  • BraveHeart Team Emphasizes Quality-First Approach

    October 16, 2018 by David Jensen, Staff Writer, MasterControl

    One trap regulated startups should try to avoid is having unrealistic assumptions about what it takes to achieve compliance. Part 3 of this article series features several members of the BraveHeart team discussing their views and expectations for quality throughout the Wearable Life Sensor’s life cycle.

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  • What Biotech Startups Need to Do to Slay the Competition

    June 21, 2018 by Matthew M. Lowe, Executive Vice President of MasterControl

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

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  • Medtech Startups: How to Survive Cutthroat Competition

    June 19, 2018 by Matthew M. Lowe, Executive Vice President, MasterControl

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 1

    May 29, 2018 by Philippe Charbon, CEO of Apsalys, a European value-added Partner of MasterControl

    The emergence of new guidelines on data integrity, and the interpretation of that data via audits and inspections, doesn't detract from pre-existing elements of regulation, particularly Annex 11 of the European Union’s (EU) good manufacturing practice (GMP) guidelines.

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  • Top 5 Up-and-Coming Trends for Nutraceuticals in 2018

    April 10, 2018 by Sarah Beale, Staff Writer, MasterControl

    Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. The industry has expanded its focus to not just provide natural, clean products but also innovative, high-quality ones. The five biggest trends for 2018 reflect this, bringing new steps and creativity to the product development process.

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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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  • Holiday Party Hosting Tip: Get an eQMS

    December 14, 2017 by David Jensen, Staff Writer, MasterControl

    It’s that time of year when we get together with family and friends and enjoy holiday festivities. Sure, all the mingling and merriment of a holiday party can be fun, but organizing an event—not so much. If you happen to be the designated planner/host of your holiday soiree, you may want to consider using an electronic quality management system (eQMS).

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  • Quality 4.0: Harnessing Technology to Enhance Traditional Quality Methods

    November 21, 2017 by Mike Rigert, Content Marketing Specialist, MasterControl

    Industries and manufacturers are increasingly approaching the challenge of digital transformation, some with caution, some with great anticipation, yet perhaps still others with unease. However, the message in a recent analyst report “Quality 4.0: Get Educated Get Involved, and Build a Successful Strategy” is clear—transform your company’s operations and efforts digitally or risk digital disruption. Forty percent of companies have already started a digital transformation initiative while another 17 percent kicked off initiatives in 2017, according to the report, which was co-sponsored by LNS Research and MasterControl.

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  • Revisiting CAPA for a More Modern (and Effective) Approach

    October 17, 2017 by Peter Knauer, Managing Partner, Sage BioPartners

    Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?

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