Validating software process

“The device manufacturer is responsible for ensuring that the product development methodologies used by the off-the-shelf (OTS) software developer are appropriate and sufficient for the device manufacturer's intended use of that OTS software.For OTS software and equipment, the device manufacturer may or may not have access to the vendor's software validation documentation.Fortunately, Minitab Nonnormal is chosen and an appropriate distribution is selected (Weibull in this case), the Ppk (0.69) and defect rate (8993 defects per million) are found to be poor, as shown in the following graph: Software packages that are used to monitor the process and determine the quality level, such as Minitab, should be validated.To validate Minitab, you will need to document the “intended use.” The validation for intended use consists of mapping the software requirements to test cases. An auditor may find that a system “has not been validated” if a requirement is discovered without a test case.All software changes shall be validated before approval and issuance.

You can download Minitab’s software validation kit here: And you can find additional information about validating Minitab relative to the FDA guideline CFR Title 21 Part 11 at this link:

Software validation is required by law for companies that operate under the purview of the FDA and EMA.

Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and .

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.

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