QSIT Guide to Inspections of Quality Systems

Guide to Inspections of Quality Systems
August 1999

This document mentions software in sections on Management controls, Design Controls, Production and Process Cotnrols and Sterilization Process Controls. SoftwareCPR provides a version of this to subscribers with all software references highlighted. The highlighted version can be found in the library under educational materials or by doing a text search for QSIT.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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