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Showing items tagged as Quality and Compliance

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

    30 July, 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

    19 March, 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

    11 December, 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

    14 February, 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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  • BraveHeart Team Emphasizes Quality-First Approach

    16 October, 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

    21 June, 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

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

    10 April, 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?

    3 April, 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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  • Trend Analysis: A Method for Focusing Resources

    20 February, 2018 by Mark Durivage, American Society of Quality (ASQ) Fellow and Managing Principal Consultant, Quality Systems Compliance

    Probably one of the most significant concerns for anyone responsible for implementing, deploying and maintaining a quality management system is the prioritization of resources. Trend analysis is one technique that can help determine if something has changed with a process (quality, production, or service). Trend analysis can be used to monitor a process, especially non-manufacturing processes such as complaints, nonconformances and deviations to aid in the decision for escalation for corrective and preventive action (CAPA).

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  • Holiday Party Hosting Tip: Get an eQMS

    14 December, 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

    21 November, 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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  • HIPAA Compliance and Data Security Demand Equal Attention

    2 November, 2017 by David Jensen, Staff Writer, MasterControl

    The Health Insurance Portability and Accountability Act (HIPAA) established by the U.S. Department of Health and Human Services (HHS) has been around since 1996. The components of HIPAA cast a wide net over regulations involving insurance coverage, medical records and tax rules. However, rapidly advancing technology and security threats are pointing a spotlight on the Privacy and Security rules that apply to electronic protected health information (ePHI).

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

    17 October, 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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  • FY2018 Increasing User Fees Affects Submission Strategy

    11 October, 2017 by Michelle Lott, Founder, Lean RAQA Systems, LLC

    Just in the nick of time at the end of August, Congress reauthorized the Medical Device User Fees (MDUFA) ensuring that FDA received vital funding to properly staff submission reviews and other activities. While the user fees for all submissions increased, de novo submissions saw the most significant increase. Historically, de novo submissions did not have a user fee. However, with FDA’s expansion of the de novo submission options to include direct de novo rather than conversion from a non-substantially equivalent 510(k) determination, the FDA was understaffed to accommodate the additional review burden. As a result, de novo submission review times could drag out 10 to 12 months.

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  • Coping with Scoping a CSV/Part 11 Audit

    21 September, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

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  • Rise of Digital Health Prompts FDA to Re-examine How It Regulates SAMD

    7 September, 2017 Jeffrey K. Shapiro, Director, Hyman, Phelps, McNamara, P.C.

    When you think about it, FDA's general regulatory paradigm for regulating medical devices has enjoyed a tremendous run. The overarching statutory and regulatory foundation was started in 1976 and largely in place in its current form by 1997. (Think 510(k)/MDR/Part 806 and QSR procedures for the postmarket phase.)

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