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GxP Lifeline

Showing items tagged as electronic document management

  • 2021-bl-infrastructure-accessibility_132x132

    3 Practical Ways to Improve Infrastructure Agility in Pharma

    If nothing else, the COVID-19 pandemic proved to pharmaceutical companies that digitally integrated processes are the key to surviving a crisis. If your organization has difficulty connecting people, processes, and systems, there are three pragmatic measures you can take to bolster your existing infrastructure, help ensure secure connections, and enhance collaborative work.

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  • Top 4 Reasons Why Documentation Reviews Are Critical to Compliance

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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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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  • Thermo Fisher Unit Thrives Thanks to Streamlined Document Management

    Call it the curse of success: as Unity Lab Services—a business unit of Thermo Fisher—flourished, the already massive amount of vital documentation that required tracking, continual updating and maintenance became exponentially larger and more difficult to manage. For a company that has obtained its leading edge by providing customers with a single source for integrated lab services, support and supply management, the very notion of out-of-control documents and outdated, rogue work instructions spelled potential disaster.

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