The validation process applied on HyperSuite® has been focused mainly on the validation of the configured components (GAMP Category 4).
The validation activities has been addressed to test its critical functions during Operational Qualification, and especially focused on Performance Qualification, in order to demonstrate that the process is consistently performing in accordance with the user specific requirements.
System Level Validation: validation of the standard part of the system (e.g. the environment that supports the creation and management of the clinical database lifecycle).
Study Level Validation: validation of a specific clinical study database. In this validation process a pilot case study has been used to validate the system at study level.