Home » Five Steps to QSR-Compliant Purchasing Controls
Five Steps to QSR-Compliant Purchasing Controls
November 22, 2021
The FDA is placing an ever-keener eye on device manufacturers’ purchasing controls, including supplier qualification processes and vendor-related record keeping, as an important part of its Quality System Inspection Technique (QSIT). Although the FDA considers purchasing controls to be a routine part of even the most basic QSIT inspection under the Production and Process Controls section of the Quality System Regulation (QSR), devicemakers are failing to meet basic requirements of 21 CFR 820.50 time and again.
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