Showing items tagged as Data Security

  • 10 Ways Cloud Technology Is Reversing a Pharma Trend

    2 July, 2019 by James Jardine, Staff Writer, MasterControl

    Cloud networks, once shunned in the life sciences, have become essential tools for pharmaceutical organizations that want to keep pace with modernized competitors and an increasingly streamlined world. Learn about 10 distinct advantages cloud technology provides to pharma companies.

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  • 7 Key Elements to Data Security and Quality Control for Pharma Labs

    28 May, 2019 by Armando Coronado and Vidhya Ranganathan, Consultants, Sequence

    Due to a growing number of U.S. Food and Drug Administration (FDA) CGMP violations involving data integrity, pharmaceutical companies are looking for ways to improve good manufacturing and lab practices. This article looks at a number of options pharma has to enhance data integrity and to ensure the safety, efficacy and quality of its products.

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  • Rise in Data Integrity Violations Prompts FDA Guidance on Data Handling

    4 April, 2019 by David Jensen, Staff Writer, MasterControl

    Noticing an increase in violations of current good manufacturing practices (CGMP) regarding data integrity, the U.S. Food and Drug Administration (FDA) drafted a question-and-answer-based guidance to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

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

    9 August, 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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  • Noteworthy Clinical Trends in Med Device to Watch in 2018

    5 July, 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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  • 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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  • Ensure Data Integrity With a Proactive Data Management Strategy

    24 July, 2018 by David Jensen, Staff Writer, MasterControl

    Data management technologies continue to evolve and improve the processes for collecting, storing and analyzing data. However, new technology rarely avoids growing pains. One dilemma regulated companies face with technology updates is maintaining data integrity. Regulatory guidelines for data integrity insist that all data and metadata remain intact and unaltered. This is a tall order when companies need to perform a large-scale data migration each time they update their data storage infrastructure. A good approach to effectively manage data and remain compliant with data integrity requirements is to develop a practical data management strategy around data storage and migration.

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  • Top Medical Device Trends in Asia-Pacific and Around the World

    15 May, 2018 by Terry Walsh, Director APAC, MasterControl

    The speed at which the medical device industry is changing and evolving is perhaps unrivaled in the life sciences industry. Medical device manufacturers are experiencing disruption from small companies and startups entering the market1, tech giants like Amazon are investigating and investing in medical device expertise and cybersecurity concerns are on the rise.

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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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  • 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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  • Cybersecurity in a Mobile World

    13 February, 2018 by David Jensen, Staff Writer, MasterControl

    Mobile device technology appears to be taking off. Lately, it seems there are more non-phone-call uses for mobile devices than there are lightbulb jokes. The healthcare industry is becoming particularly mobile device heavy. However, in terms of cybersecurity, mobile medical device technology is causing headaches for healthcare organizations.

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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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  • 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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  • Add Cybersecurity Education to Every Employee’s Job Description

    5 September, 2017 David Jensen

    The recent surge of security breaches and ransomware attacks is reinforcing the need to make cybersecurity an all-hands endeavor. Despite all the cybersecurity tools that companies are implementing, security breaches are still rampant because one of the top cybersecurity weaknesses in all industries is the lack of training employees on cybersecurity.

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  • FDA Favors Collaborative Approach to Medical Device Cybersecurity

    13 July, 2017 by David Jensen, Staff Writer, MasterControl

    Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the subject at MedTech Intelligence’s conference on Medical Device Cybersecurity.

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