21 CFR 820
An auditing checklist of all the requirements for an FDA Quality System.

We made a checklist of every suggestion of a requirement in 21 CFR 820.

[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820.1]




A checklist based on 21 CFR 820 should be a good place to start in ensuring compliance with the FDA requirements.  When using the checklist as an audit, verify the documents and records as well as practices--completeness of records is very important--but you know that.  We call the audit 8224, a customer specific audit in an ISO 9001:2000 Quality Management System under section 8.2.2 Internal Auditing.

It includes 752 questions directly related to what appear to be requirements of the standard.  The complete audit is available in MS Word format (.doc) and can be purchased online through the following Paypal link.

21 CFR 820 "shalls" audit, $49.95  

If you prefer, you can order directly:

Phone:  218-764-2787
Fax:      218-764-2786
e-mail:  wjcdesigns@chaseandchase.net
WJC Designs
15949 Greenhow Point Road
Brainerd, MN  56401

DISCLAIMER:  Use of this audit checklist does not guarantee compliance with FDA requirements.

21CFR820 "Shalls" Audit
Revision A
April 1, 2001
Supersedes: new
Changes:  Not indicated
Approval:  Wes Chase
References: 21CFR820
This document contains an audit checklist based upon the “shalls” indicated in 21 CFR 820, Quality System Regulations, of Title 21, Food and Drugs, Chapter I, Food and Drug Administration, Department of Health and Human Services.
             1.   General
             21CFR820 “Shalls” Audit Checklist

1. General
There are specific requirements or “shalls” in 21 CFR 820.  A checklist that accounts for all the apparent “shalls” should be a relatively complete audit of the system.  This will not verify that you are in complete compliance with the standard, however, but it will confirm that you have considered all the requirements.  In addition to documents, review of the records and interviews with personnel will reveal whether the people know there is a system, are aware of and actually do the requirements, and whether it is effectively implemented and maintained.

The audit checklist starts with Sec 820.5, Quality System (page 141).

In responding to a particular question, though “yes” may be the correct response, it is better to indicate how, where, what, why, and who makes the answer “yes”.  For example:  specific documents, paragraphs;  or specific records;  maybe even personal responsibilities.  You may know that “yes” is correct.  Can you prove it with hard, objective evidence other than your opinion?  This usually means a piece of paper or at least a computer screen.

Sample of audit 8224

Copyright © 2002, WJC Designs

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