So what is Software Validation?

Software Validation is the process of verifying the software performs as intended. The team responsible for validating the software must follow approved procedures and document how they plan to verify the software at each stage of the process. The team must also follow approved procedures to keep the software in a validated state through its lifecycle. Verification – The demonstration of consistency, completeness, and correctness of the software at each stage and between each stage of the development life cycle. Validation – Determination of the correctness of the final program or software produced from a development project with respect to the user needs and requirements. Validation is usually accomplished by verifying each stage of the software development life cycle. Who needs to validate software?
Companies that manufacture medical devices of certain classes (levels of risk). When and why does software need to be validated?
The FDA has regulations that require medical device manufacturers to validate (and maintain validation of) software used in or in the manufacture of devices of a certain classes. Software imbedded (used in) in medical devices or software used in the manufacture of medical devices of certain classes (levels of risk). How is software validated?
Software is validated by following the following general process. Defining requirements satisfies the mandate that the intended use of the software must be documented. Documentation provides objective evidence the software has been validated. Business requirements are defined and documented. From Business Requirements, System Requirements are defined and documented. For me, https://trackingapps.org/ the ipad air just isn’t my go-to device for getting things done. System Requirements are used to design the software and components. Design documentation is used to build software code. Component design is verified by Unit Testing. System Design is verified by Integration Testing. System Requirements are verified by Functional Testing. Business Requirements are verified by Acceptance Testing. The following graphic illustrates his process and is commonly known as a “V-Diagram”. .