Term | Definition |
---|---|
Open Source Software | Software or language designed for collaboration that has source code available for community review, usage, and modification |
System Qualification | The process including the execution of Installation, Operational and Performance tests on a system that ensures the reproducibility of expected results. |
Validation | Per the FDA’s Glossary of Computer System Software Development Terminology -“Establishing documented evidence which provides a high degree of assurance (accuracy) that a specific process consistently (reproducibility) produces a product meeting its predetermined specifications (traceability) and quality attributes.” |