eDataRepository
CIMS electronic Data Repository, eDataRepository, is build upon the backbone of CIMS eSystems functionality.
CIMS eDataRepository is build to contain and manage data and process related to regulatory requirements. The activities and control can be imbedded under the CIMS eQMS. All data access is controlled under SOPs, access limitation, history tracking, backup systems.
Data content is highly adaptable and can store any file formats.
Data can be exchanged as copies where original sources data remains non-editable and protected.
Data content can be mapped up against the content in the eTMF systems via metadata specification. This means we always know where the data is and that it is original source data.
Any upload and exchanges are following detailed process with full tracking, history and backup.