Glossary

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.”