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GHTF releases two draft guidances related to quality system audits

This article was originally published in The Silver Sheet

Executive Summary

A new Global Harmonization Task Force (GHTF) draft guidance aims to promote consistency during regulatory audits. "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy" notes that an audit should meet these objectives: "the effectiveness of the manufacturer's quality management system - including the fulfillment of regulatory requirements - is assessed in a systematic and effective manner within a reasonable time; the results of the audit are consistent regardless of which auditing organization or individual auditors conduct the audit; the audit determines how problems associated with a medical device or the quality management system are recognized and addressed; and the audit is transparent to the auditee." The draft is dated May 11 and was posted online Sept. 16. A second proposed document, "Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers - Part 4: Multiple Site Auditing," is intended to be used in conjunction with the "Regulatory Auditing Strategy" draft document, GHTF says. The Part 4 document applies specifically to audits of multiple sites operating under the same quality management system, and does not apply to firms that have multiple businesses employing separate and distinct quality management systems. The Part 4 draft is dated July 1 and also was posted online Sept. 16

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