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GxP Lifeline

Showing items tagged as Data Security

  • 2022-bl-data-integrity-strategy_132x132

    How to Avoid Warning Letters for Data Integrity Nonconformances

    According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.

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  • engineer-showing-automation-system-132

    3 Key Elements to Data Security and Quality Control for Pharma Labs

    Data integrity in the drug industry is a vital element to ensure the safety, efficacy, and quality of drugs. Data integrity has remained an industry buzzword for many years, but the experience the industry has gained from shortened timelines of COVID-19 vaccine development and manufacturing has further strengthened its importance.

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  • 2020-bl-matt-brawner-qa_132x132

    An Expert Explains Data Integrity and Organizational Excellence – Part One

    Data integrity is closely related to organizational excellence. An expert explains best practices and mistakes to avoid.

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  • MasterControl Logo

    The Challenges of Cloud Compliance in a Regulated Environment

    Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.

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  • 2020-bl-ipass-integration_132x132

    Integration Is the Fast Lane to Data

    A platform approach is the ideal way to handle software solutions across an organization. However, no software provider has every type of software that a company might need. That’s why integration platform as a service (iPaaS) is so vital. It bridges the gap between solutions and gives you better control over your data.

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  • 2020-bl-thumb-5-myths-about-cloud-security

    Webinar Dispels Myths About Cloud Security

    More companies in all industries are migrating to a cloud environment to benefit from the advanced computing power, abundant data storage, and ability to perform complex functions. The cloud provides significant value; however, security has often been a source of concern. This article dispels the five most common myths about cloud security.

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  • 2019-bl-thumb-respost-cloudly-with-chance-of-awesomness

    How Cloud Migration Has Become More Seamless for Regulated Companies

    Cloud technology has reached a level of maturity where many regulated companies are discovering that operating in the cloud is more cost effective and a competitive advantage. A new white paper discusses the benefits of moving to the cloud and how companies can make the migration process smoother and faster.

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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-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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  • 2020-bl-connectivity-02_132x132

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

    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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  • 2020-bl-connectivity-03_132x132

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

    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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  • 2018-bl-thumb-top-med-device-trends-asia-pacific

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

    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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  • 2018-bl-thumb-british-mhra

    UK's MHRA Issues Final Guidance on GxP Data Integrity

    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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  • 2018-bl-thumb-eus-gdpr

    GDPR Deadline Approaches: What Is Expected for Compliance?

    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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  • 2017-bl-thumb-mobile-device-cybersecurity

    Cybersecurity in a Mobile World

    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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  • 2017-bl-coping-with-scoping-page-image

    Coping with Scoping a CSV Audit

    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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