The purpose of this Compliance Checklist CFR 820 is to verify that a organisation is complainant to 21 CFR 820 Quality System Regulations. This evaluation checklist can be used as part of a supplier evaluation or audit process or as an checklist for internal auditing or to perform a gap analysis as part of any compliance program or inspection readiness initiative.

US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 820

Table of Content:

1          Purpose & Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

4          Definitions

5          Procedure

5.1       820.20 – Management Responsibility

5.2       820.22 – Quality Audits

5.3       820.25 – Personnel

5.4       820.30 – Design Controls

5.5       Design and Development planning

5.6       Design Input

5.7       Design Output

5.8       Design Reviews

5.9       Design Verification

5.10      Design Validation

5.11      Design Transfer

5.12      Design History File

5.13      820.40 – Document Controls

5.14      820.50 – Purchasing Controls

5.15      820.60 – Identification

5.16      820.65 – Traceability

5.17      820.70 – Production and Process Controls

5.18      820.72 – Inspection, Measuring, and Test Equipment

5.19      820.75 – Process Validation

5.20      820.80 – Receiving, in-process, and finished device acceptance

5.21      Receiving acceptance activities

5.22      In-Process acceptance activities

5.23      Final Acceptance Activities

5.24      820.86 – Acceptance Status

5.25      820.90 – Non-Conforming Product

5.26      820.100 – Corrective and Preventive Action

5.27      820.120 – Device Labeling

5.28      820.130 – Device Packaging

5.29      820.140 – Handling

5.30      820.150 – Storage

5.31      820.160 – Distribution

5.32      820.170 – Installation

5.33      820.180 – General Requirements

5.34      820.181 – Device Master Record

5.35      820.184 – Device History Record

5.36      820.186 – Quality System Record

5.37      820.198 – Complaint Files

5.38      820.200 – Servicing

5.39      820.250– Statistical Techniques

6          Attachments

Size and Format of the Compliance Checklist CFR 820:

• Microsoft Office 2003
• Word File
• 24 pages checklist – gap analysis

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