At Minitab, we recognize that our high-quality software products must meet the needs and expectations of our customers. We also recognize that many of our customers desire information on how we validate our software, and may need information from us to help satisfy regulatory agency requirements. To address that need, we have created the tools and documents in this software validation kit.
The kit provides information about the processes and practices we use to assure the accuracy and reliability of all statistical output. It also includes a description of our Vision Statement, Quality Policy, Software Development Life Cycle, and an automated script for performing a representative set of analyses. The output from this script can be compared to a validated output file to help you verify that you are getting the same results on your particular hardware configuration. The script can also be used as a template for your own validation efforts.
Note that no one part of this kit will necessarily satisfy the validation requirements of regulatory agencies. We validate for market readiness only, and hope that these materials will facilitate your own efforts in validating the software and showing that it is fit for use in your environment.
Download the Minitab 16 Software Validation Kit (ZIP file)
If your software validation process also requires adherence to FDA regulation CFR Title 21 - Part 11, you can find additional information about this regulation and Minitab Statistical Software at:
http://www.minitab.com/support/answers/answer.aspx?id=2588
This software validation kit was created to help you understand how we validate Minitab Statistical Software for market readiness, and to confirm Minitab’s continued commitment to quality. If you have any questions about our software validation process, please Contact Us.
