No Need to Validate the Software in Design and Development? Wrong!

No Need to Validate the Software in Design and Development? Wrong!

September 9th, 2013 // 10:22 pm @

Recent FDA Compliance News

You might be surprised how many professionals think that they don’t need to validate the software/automated test equipment in their design and development processes. This is not correct! If you are utilizing a software tool or any kind of automated test to do design or design verification OR validation, then the data that is generated is very important to your graps of the design, or the verification of the design or the results of the validation.

This requirement also applies to the software tools that are utilized to create medical device software, or also the test software writing for your production environment. Note that 21 CFR Part 820.70(i) mandates that all software that is utilized in the quality system has to be validated for the intended use. This will include any software that you use in design.

If you use a test method for verification of design or validation that was not in the past validated or qualified, you will need to make sure that it has been validated or qualified properly before it is used. This must include any that were not automated and it is even more vital for any simulated use tests that you do for your design validation. If you are using standard methods, which is documented in a national standard or an approved international standard, you do not need to worry about this. Just be sure that you can provide evidence that the test set up has met the standard, and that you did the test as it was specified in your standard.

If you were the designer of the test method, you will then need to do enough validation activities to show that your test method will give data that is entirely accurate, appropriate, and repeatable.

If you have questions about software validation, please review our upcoming Sept. 26 webinar, FDA Compliant Strategic Software Validation Planning for Senior Management.


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