Title 21 CFR Part 11: Test Protocols

January 25, 2012 by
Filed under: Compliance, Healthcare, Regulatory 

I mentioned in an earlier post about protocols, in this post I will describe in detail what this looks like and how it is modeled to be successful.

It is important to note that Standard Operating Procedures (SOPs) are required in order for the system to work as a legal framework and the SOPs will dictate the structure, flow, and process around the documents in a system, SOPs are essentially the core principals to any regulated company.

Parts of a Protocol for validation of software

1 – Approvers

2 – Environment & Setup

3 – Defect Tracking

4 – Test Cases

5 – Test Results

Appendix – This could be a test execution worksheet documentation of the evidence that testing took place.

Part 1 – Approvers

This is a list of people and titles and signatures needed to approve the test protocol, once signed it is in effect, however signing this doesn’t complete the testing it just completes the definition of how to test.

Part 2 – Environment

Describes the system environment testing is being completed in.

Part 3 – Defect Tracking

This is very important what do you do, if when testing a test fails?  You need to track the whole process to ensure it gets documented, fixed or not and risks justification.

Part 4 – Test Cases

These are step-by-step instructions on the testing, it is good idea to track each test case to a requirement to ensure that you can prove you are meeting the definitions of the function of what the software should do.

Part 5 – Test Report

This is the summary of what you will record when testing is complete, how it is recorded and processes around the record keeping.


Usually contains templates or worksheets and review sheets as documented evidence of the testing.

See an example template in MS Word 2010

Example Test Protocol (word 2010): Download here


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