Showing items tagged as electronic submissions

  • 2021-bl-weaver-logo_132x132

    Weaver and Company: Digitization Streamlined Quality and Production

    Since its founding in 1978, medical device manufacturer Weaver and Company has grown, regulations relevant to its products have evolved, and paper-based processes posed greater risk. Recognizing that managing paper quality and production documents was no longer practical, the Colorado-based company has taken steps to modernize with MasterControl's digital quality management and manufacturing solutions.

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  • 2018-bl-thumb-manufacturing-software-trends-july-2018

    The #1 Gap in Manufacturing Software Today

    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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  • MasterControl Logo

    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-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published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

    In February of 2014, the FDA issued a final rule amending 21 C.F.R. Part 803, Medical Device Reporting, to require medical device manufacturers and importers to submit initial and supplemental MDRs in an electronic format via the Electronic Submissions Gateway (ESG), rather than in paper form through Form FDA 3500A. The compliance deadline of August 14, 2015, is fast approaching! Will you be ready?

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