Showing items tagged as Validation

  • Avoiding a Time Traveler’s Mindset With Effectiveness Checks

    July 27, 2020 by Sarah Beale, Staff Writer, MasterControl

    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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  • Leveraging GAMP Compliance for Risk-Based Computer Validation

    March 31, 2020 by Mike Rigert, Staff Writer, MasterControl

    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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  • Top 4 Takeaways From Validation Week

    November 12, 2019 by Sarah Beale, Staff Writer, MasterControl

    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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  • Top Trends for New and Improved Validation

    November 7, 2019 by Sarah Beale, Staff Writer, MasterControl

    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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  • Top 5 Takeaways From IVT’s Data Integrity Validation Conference

    October 10, 2019 by David Jensen, Staff Writer, MasterControl

    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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  • A Guide for Performing and Maintaining a Validated IT Infrastructure

    July 9, 2019 by Ian Lucas, Partner and Director, SeerPharma

    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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  • Avoid FDA Audit Findings on Your Device by Performing Process Validation

    June 27, 2019 by Dan O'Leary, President, Ombu Enterprises

    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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  • 4 Common Fears and Misconceptions About Cloud Validation

    May 23, 2019 by Cindy Fazzi, Staff Writer, MasterControl

    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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  • Technical Validation: A Bottleneck in the Drug Registration Process?

    April 3, 2019 by Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO

    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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  • Why the Cloud Is the Key to Easing Your Validation Burden

    August 16, 2018 by Cindy Fazzi, Staff Writer, MasterControl

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

    August 9, 2018 by David Jensen, Staff Writer, MasterControl

    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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  • Using a QMS to Qualify Your Suppliers

    August 2, 2018 by Sarah Beale, Staff Writer, MasterControl

    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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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    July 5, 2018 by James Jardine, Staff Writer, MasterControl

    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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  • Necessity Is the Mother of a Groundbreaking Validation Tool

    April 26, 2018 by Cindy Fazzi, Staff Writer

    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

    April 24, 2017 Cindy Fazzi, Staff Writer, MasterControl

    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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  • Validation of Off-the-Shelf Software

    April 19, 2017 David S. Brown, President of David S. Brown LLC, A Consulting Firm

    "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!

    February 2, 2017 by Lisa Weeks, Staff Writer, MasterControl

    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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  • Identifying and Preventing Common Data Integrity Issues

    September 20, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

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  • 6 Steps to Simplify Software Validation

    September 10, 2015 Kevin Ballard, Director of Software Validation, MasterControl

    Validation is one of the most time-consuming and resource-intensive activities when implementing eQMS software in a regulated environment, often delaying implementation and an organization’s ability to go live with new software.

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  • Change in Pharmaceutical Manufacture

    May 28, 2015 Peter Murray, Consultant

    Within the pharmaceutical industry, the concepts of validation, change, change control, deviation and out of specification (OOS) are often treated as distinct activities which operate with a significant degree of independence.

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