• Apply ISO 9001:2015’s HLS for Improved Document Control and Compliance

    5 March, 2019 by Mike Rigert, Staff Writer, MasterControl

    ISO 9001:2015 is currently a key focus for transition for many life science and other regulated industry organizations. The high level structure (HLS) format within the standard has explicit requirements and when implemented with a robust quality management system (QMS), can help companies improve their document control processes and compliance levels.

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  • Using Sherlock Holmes to Pick a Consultant

    23 January, 2019 by Sarah Beale, Staff Writer, MasterControl

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

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  • Costs of Paper: Hard vs. Soft ROI

    23 January, 2019 by Bryant Headley, Sr. Director of Regulatory Affairs and Executive Government Liaison, MasterControl

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.

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  • What's Hiding in Your Labeling Artwork?

    23 October, 2018 by Dan Vuksanovich, Regional Sales Manager, Schlafender Hase

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

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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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  • Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    28 June, 2018 by David Jensen, Staff Writer, MasterControl

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

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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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  • The Link Between Regulation, Quality Systems and Data Integrity, Part 2

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

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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

    29 May, 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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  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • How to Minimize Protocol Deviations

    1 May, 2018 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Poll Suggests Automation Could Solve 85% of Your Document Control Issues

    20 March, 2018 by Mike Rigert, Staff Writer, MasterControl

    The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.

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  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    1 September, 2017 by David Cornwell, Founder/CEO, PleaseTech Ltd.

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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