• Three C’s That Will Matter for Manufacturers in a ‘Post-COVID-19’ World

    16 June, 2020 By Rai Chowdhary, CEO of KPI System (Key Performance Improvement)

    The time for manufacturers to prepare for a post-COVID-19 world is now. Re-calibrate for the "new normal" by looking to these "three c's" for guidance.

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  • How Harmonizing 21 CFR Part 11 and Data Integrity Delivers Higher Quality Products

    14 May, 2020 by David Jensen, Staff Writer, MasterControl

    Complying with the many record and data management requirements for 21 CFR Part 11 and data integrity can be daunting. In this article, Matt Brawner, data integrity subject matter expert (SME) at Sequence Inc., explains how companies can integrate Part 11 and data integrity processes to accelerate pathways to approval and deliver higher quality products to market.

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  • An Assessment of the ‘Elevens’: EU’s Annex 11 and FDA 21 CFR Part 11

    13 November, 2019 by Mike Rigert, Staff Writer, MasterControl

    The European Union’s Annex 11 and the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 good manufacturing practice (GMP) guidances cover much of the same regulatory ground but also have differences. Find out how both regulatory documents affect life sciences manufacturers.

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  • Q&A: EpiBone on Digitizing and Automating Their Production Records

    22 August, 2019 by David Butcher, Staff Writer, MasterControl

    In this Q&A, EpiBone’s quality assurance manager and quality assurance specialist explain why and how the Brooklyn-based regenerative medicine company chose to digitize and automate their production records with MasterControl’s Manufacturing Excellence solution.

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  • Data Integrity: Trends, Pitfalls, Solutions, and Why DI Is Still Making Headlines

    7 March, 2019 by Matt Brawner, Director of Sales Execution, Sequence

    In a modern, technological era with an ever-increasing amount of data and data systems, robust data integrity is crucially important, particularly for life science and other regulated industries. Learn the latest best practices to properly ensure that you company’s data is complete, consistent and accurate.

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  • Regulatory Barriers to Innovation for Startups

    31 July, 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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  • The #1 Gap in Manufacturing Software Today

    18 July, 2018 by Beth Pedersen, Staff Writer, MasterControl

    It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

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  • Necessity Is the Mother of a Groundbreaking Validation Tool

    26 April, 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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  • 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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  • When GCP & GMP Meet

    30 May, 2017 by Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Developing safe and effective drugs requires a coordinated effort across a diverse set of disciplines. This is easier to observe at some points in the process than at others. Once a product is well into human trials, it can be easy to forget that developments on the manufacturing side of the house can affect the clinicians who are conducting the studies.

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

    24 April, 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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