21-CFR 820 Quality systems GMP Checklist

This ready-to-use 21 CFR 820 quality audit questionnaire (audit by mail) has been created for the assessment of potential device suppliers that need to comply with the US FDA regulatory requirements set out in 21 CFR 820. The checklist will help you evaluate potential suppliers and cut costs and outlay. This 26-page checklist covers all sections of 21 CFR 820. It can also be used as an inspection checklist for internal or external audits.

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Table of Contents:

Subpart B - Quality Systems Requirements
Section 820.20 – Management Responsibility
Section 820.22 – Quality Audits
Section 820.25 – Personnel
820.30 – Design Controls
Subpart D – Document Controls
820.40 – Document Controls
Subpart E – Purchasing Controls
820.50 – Purchasing Controls
Subpart F – Identification and Traceability
820.60 – Identification
820.65 – Traceability
Subpart G – Production and Process Controls
820.70 – Production and Process Controls
Subpart H – Acceptance Activities
820.80 – Receiving, in-process, and finished device acceptance
820.86 – Acceptance Status
Subpart I – Non-Conforming Product
820.90 – Non-Conforming Product
Subpart J – Corrective and Preventive Action
820.100 – Corrective and Preventive Action
Subpart K – Labeling and Packaging Control
820.100 – Device Labeling
820.130 – Device Packaging
Subpart L – Handling, Storage, Distribution, and Installation
820.140 – Handling
820.150 - Storage
820.160 - Distribution
820.170 - Installation
Subpart M – Records
820.180 – General Requirements
820.181 – Device Master Record
820.184 – Device History Record
820.186 – Quality System Record
820.198 – Complaint Files
Subpart N – Records
820.200 – Servicing
Subpart O – Statistical Techniques

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