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Global Harmonization Task Force In Brief

This article was originally published in The Gray Sheet

Executive Summary

Regulatory auditing strategy: The global Harmonization Task Force has released a working draft 1document titled "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy." The document provides guidance to regulators and auditing organizations on how to conduct a manufacturing quality system audit. It is also expected to benefit manufacturers through improved auditing, leading to improved quality management systems and product quality; easier preparation for audits due to greater consistency in audit practices; a reduction in the number of times a single manufacturer undergoes audits by different regulatory bodies; and increased confidence in and acceptance of audits by different regulators, the document says. The draft is dated May 11 and was posted online Sept. 16

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