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GxP Lifeline

Showing items tagged as electronic submissions

  • 2021-bl-eifu-impact-on-qms_132x132

    The Impact of Implementing an eIFU Solution on Your Quality Management System

    Electronic instructions for use (eIFU) are just as compliant as paper ones, but any implementation of a new system is going to affect existing ones. In particular, the quality management system (QMS) will need to be updated in certain areas to prepare for the switch.

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published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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