eTechnicalFile
CIMS electronical Technical File eTechnicalFile is build upon the backbone of CIMS eSystems functionality CIMS eTechnicalFile contains the elements of technical documentation minimum requirements from the 2017/745 MDR regulation. All documents can be created on templates, uploaded from other systems, edited and follow the path of review, approval, eSignature, storage as all CIMS eSystems.
Pre-clinical and Clinical data can reside in the repository of the eTechnicalFile or can be linked from the CIMS eTMF as the trial documentation and eDataRepository containing the data.