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Software Tool Validation for the FDA

on Sep 14, 10 • by Brendan Harrison • with No Comments

We get many questions from medical devices customers on how they should validate the use of Klocwork’s static analysis tools for the FDA. I suspect the situation would be similar for most vendors of software development tools. As we’ve done before, we thought it would be a good idea to ask Bruce Swope from...

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We get many questions from medical devices customers on how they should validate the use of Klocwork’s static analysis tools for the FDA. I suspect the situation would be similar for most vendors of software development tools. As we’ve done before, we thought it would be a good idea to ask Bruce Swope from SterlingTech Software to clarify this whole topic for us.

[Brendan] First, what is tool validation?
[Bruce] Tool validation is the act of demonstrating that a tool will consistently produce expected results.

[Brendan] How can a medical device company know whether they should validate a tool or not?
[Bruce] From 21CFR820.75, “Where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”. For example, if you are using a tool to perform work and you do not plan on using any other method to verify that the work was done properly then the tool will need validation. Please note that you must validate the tool for your intended use, not the entire tool.

FDA Tool Validation Checklist

FDA Tool Validation Checklist

[Brendan] Ok, let’s take a specific example. What would validating a static analysis tool involve? 
[Bruce] Here’s a basic list of what needs to be completed.

a) Develop a Tool Validation Plan. This should include the test environment and methods to be used
b) Develop a set of requirements that the tool is intended to meet
c) Develop a test protocol to verify that the requirements have been met
d) Develop a traceability matrix and verify that all requirements have been tested
e) Execute the test protocol
f) Write a test report summarizing the results

[Brendan] Do most companies do this themselves or can they outsource this activity? 
[Bruce] If the company has the internal trained resources available then they can certainly do the tool validation themselves. Many companies lack the staffing, or expertise, to perform validation of a software tool. It is common for these companies to outsource the documentation and testing activities to a firm like SterlingTech. We’ve completed this process numerous times before and it’s a good way to reduce the cost and effort around the validation process.

[Brendan] Thanks Bruce.

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