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Includes:
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21 CFR Part 11 - Electronic Records; Electronic
Signatures
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21 CFR Part 803 - Medical device reporting
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21 CFR Part 806 - Medical devices; reports of
corrections and removals
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21 CFR Part 820 - Quality system regulation
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21 CFR Part 821 - Medical device tracking
requirements
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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
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Medical Device QSIT
Combination Handbook - $9.90 ea.
Custom Logos Available!
Other Book Options:
If you would like
to add any other combination to this handbook, call
856-810-1825.
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