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.
Let’s say they use Minitab’s Capability Analysis Normal to perform the capability analysis.
The application, as well as the benefits of using ALM platforms in the development of medical device software have been thoroughly documented by Application Lifecycle Management solution vendors (see this blog post) and medical device developers alike.
Minitab does extensive testing to validate our software internally, but Minitab’s statistical software is not—and —FDA-validated out-of-the-box. It is a common misconception that software vendors can go through a certification process to achieve FDA software validation. Software vendors who “When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.
All software changes shall be validated before approval and issuance.
In other words, if you’re using an Application Lifecycle Management solution such as code Beamer ALM to support your medical device software development, validating it is necessary in order to comply with FDA’s relevant regulations.