Includes:

• 21 CFR Part 11 - Electronic Records; Electronic Signatures

• 21 CFR Part 803 - Medical device reporting

• 21 CFR Part 806 - Medical devices; reports of corrections and removals

• 21 CFR Part 820 - Quality system regulation

• 21 CFR Part 821 - Medical device tracking requirements

• QSIT - Quality Systems Inspection Technique Manual

This document provides guidance on an inspectional process that may be used to assess a medical device manufacturer’s compliance with the Quality System Regulation and related regulations. The inspectional process is known as the “Quality System Inspection Technique” or “QSIT”.

QSIT Includes:

• Management controls
• Design Controls
• Corrective and Preventive Actions (CAPA)
• Production and Process Controls (P&PC)
• Sampling Plans