Showing items tagged as Validation

  • 2020-bl-risk-based-approach-validation_132x132

    A Risk-Based Approach to Validation

    Updated guidances for process validation suggest using a risk-based life cycle management approach with relevant scientific rationale and evidence in lieu of a traditional top-down comprehensive approach. This article presents an approach to risk management for successfully meeting the regulatory guidelines for validation.

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  • 2020-bl-process-verification_132x132

    Process Verification vs. Process Validation: What You Need to Know

    Knowing if a manufacturing process needs to be verified or if it needs to be validated is often a conundrum for medical device makers. Learn the difference between the two compliance-critical activities and circumstances when each is required.

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  • 2020-bl-cloud-ultimate-guide2_132x132

    Cloud-based QMS Launches in Australia

    MasterControl’s cloud-based quality management system (QMS) is now available in Australia. An increasing number of businesses are modernising their operations and discovering the advantages of cloud computing. Explore the ways cloud technology makes it possible to enhance your competitive edge.

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  • 2020-bl-better-effectiveness-checks-thumbnail

    Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).

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  • 2020-bl-thumb-gamp-for-risk-based-computer-validation

    Leveraging GAMP Compliance for Risk-Based Computer Validation

    In a life sciences industry that highly values risk reduction, Good Automated Manufacturing Practices (GAMP) principles offer key insights on computer validation. GAMP 5 offers companies guidelines that can help ensure greater computer system compliance that reduces risk.

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  • 2019-bl-thumb-validation-conference-takeaways

    Top 4 Takeaways From Validation Week

    In October, the 25th Annual Validation Week was held in Las Vegas, Nevada. The presenters included current and former employees of the U.S. Food and Drug Administration (FDA), and validation experts from the life sciences. This article explores the prevalent themes from the conference and how they will change validation.

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  • 2019-bl-thumb-top-trends-new-improved-validation

    Top Trends for New and Improved Validation

    Technology’s getting more advanced and our validation practices are finally starting to catch up. During the 2019 Masters Summit, Validation Product Manager Erin Wright gave us a glimpse at what’s in the future. Read about the next big trends in validation, including the U.S. Food and Drug Administration’s (FDA) stance.

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  • 2019-bl-thumb-data-integrity-conf-takeaways-1

    Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    The Institute of Validation Technology (IVT) recently hosted its fifth annual Data Integrity Validation conference (Aug. 14-15) in Waltham, Massachusetts. Subject matter experts from a variety of life sciences industries discussed critical aspects of data integrity and why it remains one of the most common inspection findings. This article highlights the valuable insights attendees gained about data management technologies and best practices.

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  • 2019-bl-thumb-infrastructure-qualification-seer-pharma

    A Guide for Performing and Maintaining a Validated IT Infrastructure

    It’s essential for life sciences and other regulated companies to certify that their IT infrastructure is up to specifications through system validations and qualifications, not only for better compliance, but also to ensure the quality and integrity of their data and production documentation.

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  • 2019-bl-thumb-process-validation-for-medical-devices

    Avoid FDA Audit Findings on Your Device by Performing Process Validation

    Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.

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  • Tips for Life Science Companies to Thrive in a Digital Era | MasterControl

    4 Common Fears and Misconceptions About Cloud Validation

    Unsure about cloud validation? You’re not alone. Many life sciences and other regulated companies are unfamiliar with cloud-based quality management system (QMS) and wary about its validation. After all, their regulatory compliance is at stake.

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  • 2019-bl-thumb-technical-validation-bottleneck-registration-process

    Technical Validation: A Bottleneck in the Drug Registration Process?

    In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.

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  • 2018-bl-thumb-fda-veteran-lists

    Why the Cloud Is the Key to Easing Your Validation Burden

    If your organization spends several weeks or months performing software validation, you’re not alone. Most regulated companies do. But, Erin Wright, MasterControl’s validation product manager, said validation doesn’t have to be as burdensome anymore. The powerful cloud technology, combined with a risk-based approach, is the key to a faster and better validation process.

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  • 2018-bl-thumb-top-5-med-device-industry-trends-software complex

    Top 5 Medical Device Industry Trends in 2018: Software Is More Common and Complex

    The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.

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  • 2018-bl-thumb-top-5-nutraceutical-trends-qualifying-suppliers

    Using a QMS to Qualify Your Suppliers

    Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.

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  • 2018-bl-thumb-clinical-trends-med-device

    Noteworthy Clinical Trends in Med Device to Watch in 2018

    Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.

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  • 2016-nl-bl-thumb-cfda

    Necessity Is the Mother of a Groundbreaking Validation Tool

    It has been proven time and again that necessity is the mother of invention. From the printing press to electric cars, the story is similar. The printing press answered the need for a more rapid dissemination of information during the Renaissance, while the electric car is a response to the need for a zero-emission car today. In regulated environments, the dire need to lighten the software validation burden led to the development of a groundbreaking application.

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  • 20 Years Later, 21 CFR Part 11 is More Relevant than Ever

    If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

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  • 2020-bl-future-trends-opportunities_132x132

    Validation of Off-the-Shelf Software

    "Previously published on www.MedicalDeviceSummit.com, Copyright: Innovative Publishing Company, LLC. Reprinted with permission"

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  • Your Top 10 Questions About ISO 13485:2016—Answered!

    In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise

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