GxP Lifeline

 

Showing items tagged as electronic document management

  • 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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  • Thriving in a Digital Era, Part 1

    27 March, 2019 by David Jensen, Staff Writer, MasterControl

    Another phase of the industrial revolution — dubbed Industry 4.0 — is underway and gaining momentum. While the previous phases of the industrial revolution have been about adopting new technologies, Industry 4.0 is about redefining the organizational culture.

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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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  • 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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  • Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • FDA Guidance Answers Questions Regarding Data Integrity

    23 March, 2017 by David Jensen, Staff Writer, MasterControl

    An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “

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  • Better IT Tools Mean Better Results

    1 December, 2016 David Cornwell

    An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information. Document collaboration is an increasingly common component of these workers’ daily tasks. In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.

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  • Thermo Fisher Unit Thrives Thanks to Streamlined Document Management

    28 June, 2016 James Jardine, Marketing Communications, MasterControl Inc.

    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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  • Don’t Trip over These 9 Document Control Pitfalls

    26 April, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    25 February, 2016 James Jardine, Marketing Communications, MasterControl Inc.

    If a document control system exists to improve your organization’s productivity and help maintain a continual state of audit readiness, what rudimentary features does it absolutely need to have? The components that are deemed essential may vary slightly from one organization to the next based on individual business requirements, but the following checklist covers the minimum functionality that should be expected from a categorically complete document control software solution.

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  • Holistic CQMS: The Modern Model of Clinical Trial Management

    23 November, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    The life science industry is experiencing a transformation in the clinical trial management paradigm. The timeworn clinical trial management system (CTMS) archetype is being increasingly supplanted by a more comprehensive and efficient clinical quality management system (CQMS) model.

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  • eTMF Management: Don’t Settle for a One-Trick Pony!

    12 November, 2015 Patricia Santos-Serrao, MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    Organizations searching for an electronic trial master file (eTMF) solution are likely to stumble upon various vendors claiming to be the “industry leader in eTMF” or some variation of this statement. With so many vendors claiming to be leaders, what does that mean to be a leader in eTMF? Should it factor into my decision as I evaluate and choose a solution for my organization? The answers to that question may not be a clear cut as one may think.

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  • EDMS Evolution: Automated Document Management as a Differentiator

    1 October, 2015 James Jardine, Marketing Communications, MasterControl Inc.

    Thirty years ago, only the most elite, cutting-edge manufacturers had electronic document management systems. But 30 years ago we also had cassette players in our cars, memberships to Blockbuster video, and spare change for payphones. Over the past three decades, electronic document management systems (EDMS) have had the same “creative disruption” effect on manufacturers that streaming television services, online booksellers, tax software, and travel websites have had on the rest of the economic landscape.

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  • Avoiding Remediation with a Good QMS

    15 May, 2013 Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

    Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic document management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justif

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