• Software Validation

    At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products. We employ rigorous testing methods such as automated regression tests, manual calculations, and comparison with other notable benchmarks to validate proper functionality of the software and numerical accuracy of results. Our number one quality objective is to provide results you can trust.

    Recognizing that many businesses must meet FDA and other regulatory agency requirements by validating software according to their intended use, we provide a Minitab 18 Software Validation Kit to facilitate our customers’ validation efforts. The kit includes information about our software testing procedures and an automated script of representative analyses with instructions for use. The output you generate from the script can be compared to an output file we have validated internally. If the script does not cover all the tools you use, it can be used as a template for your validation efforts or you can contact our consultants for assistance.

    Download the Minitab 18 Software Validation Kit

    For clarifying examples regarding software validation, visit the Minitab blog.

    If your software validation process requires adherence to FDA regulation CFR Title 21 - Part 11, you can find more information about this regulation and Minitab Statistical Software at:

    Minitab and Compliance with CFR Title 21 – Part 11 - ID 2588

    For additional questions about our internal software validation process, please contact us.

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