CIMS eSystems is a 21 CFR part 11 compliant data, records and documents storages system. It is used for the storages of GxP required records and documents.

The system has adaptability toward sponsors preferred development file management.

The system is built up in three levels C, B, A.

C level is fully adaptable and used as development platform with all SharePoint features as history, user administration, co-authoring, app integration, sharing, task assignment.

B Level is the structured signature level where signed records and documents coming from level C is being archived and history of activities are be stored.

A level is pure archive and repository storage, where the records and documents coming from level B, relevant for authorities, are being stored in a relevant file structure.

The backbone of CIMS eSystems functionality can be used in numerus settings:

• As pure eQMS
• As eTMF in Clinical development
• As Data Repository and exchanges platform
• As Submission storages
• As signature platform
• Or fully integrated

Read more about usage here: 

eQMS
eTechnicalFile
eTMF
eDataRepository
ePMCF

CIMS eSystems can be customized to meet the specification from clients with only the minimum necessary requirements to fulfil the operating environment from the client.

The system is supported by CIMS SOP templates which will be adapted to the client’s procedures with the prerequisites of staying in compliance.