Showing items tagged as electronic submissions

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published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

    15 July, 2015 Alex Butler, Product Manager Life Science Applications (LS APPs), MasterControl

    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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  • How the New FDA Final Rule and Guidance on Electronic Submissions Will Impact Devicemakers

    17 July, 2014 by Lisa Weeks, Marketing Communications, MasterControl

    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, rather than in paper form through Form FDA 3500A. The “Final Rule” will take effect on August 14, 2015, which means you have only 13 months to revise your MDR procedures to comply with the new requirements and to secure a production account for submitting eMDRs to the FDA. Will you be ready?

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  • Report from MD&M West Conference: Navigating through the PMA and 510(K) Submission Processes

    15 April, 2014 by Peter Knauer, Senior QCC Consultant, MasterControl Inc.

    I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conferen Trouble-Free Validation with MasterControl (1:38)ce. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

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