The decision to implement system functionality using software is one that is typically made during system design. Software requirements are typically derived from the overall system requirements and design for
those aspects in the system that are to be implemented using software. There are user needs and intended uses for a finished device, but users typically do not specify whether those requirements are to be met by hardware, software, or some combination of both. Therefore, software validation must be considered within the context of the overall design validation for the system.
A documented requirements specification represents the user's needs and intended uses from which the product is developed. A primary goal of software validation is to then demonstrate that all completed
software products comply with all documented Pharma software and system requirements. The correctness and completeness of both the system requirements and the software requirements should be addressed as part of the design validation process for the device. Software validation includes confirmation of conformance to all software specifications and confirmation that all software requirements are traceable to the system specifications. Confirmation is an important part of the overall design validation to ensure that all aspects of the medical device conform to user needs and intended uses.
good manufacturing practices
Current good manufacturing guidelines
21 CFR Part 11 Requirements
Medical Device 510(k) Clearances
Software validation Regulatory Requirements
Benefits of software validation in medical devices and pharmaceuticals