Software Validation
The validation of computer systems performing regulated operations provides confirmation by examination and provision of objective evidence that computer system specifications conform to user needs and intended users, and that all requirements can be consistently fulfilled. Good computer and software validation requires planning, verification, testing, traceability, configuration management and many other aspects of good software engineering, that together help to support a final conclusion that software is validated. Software validation is a part of the design validation for a finished device, but is not separately defined in the Quality System regulation. In practice, software validation activities may occur both during, as well as at the end of the software development life cycle to ensure that all requirements have been fulfilled.
Software Validation & Testing
In order to facilitate the validation and testing of software systems in the most time and cost-efficient manner possible, we follow a proven process of:
- Conducting an assessment of critical needs for the validation of software
- Drafting software validation project specifications for client approval
- Developing a matrix of testing scripts tailored to meet those objectives
- Reporting the results of our comprehensive testing, including completeness metrics
- Re-validation to accommodate changes resulting from ongoing upgrades and system maintenance
- Maintaining a state of compliance for the validated software
