Product Configuration Management Process
This process controls the configuration scope and release along the lifecycle of the product. A product configuration version is generated by linking it together with all performance relevant components with its individual versioning information.
The process relies on an analysis of performance relevant factors in product design (... identified elements to be put under version control then).
The configuration management plan also describes the interfacing of platform versions with reagent lots. To the end of a product development, configuration scope and release is determined by individual changes of the components (e.g. software design change, obsolescence new vendor for disposable).