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Integrin supports  Electronic Records / Electronic Signature that complies with FDA Regulation 21 CFR Part 11, Integrin is a closed system i.e. only authenticated users can login to the system and access is limited by User Role, Integrin complies with Controls for closed systems recommendation in 21 CFR Part 11, Integrin can generate electronic copies of the records stored in the system in human readable and electronic form suitable for inspection, review, and copying by the agency; Only authenticated and authorized users can retrieve the stored electronic records, throughout the records retention period and can sign an electronic record or perform an operation.

Integrin supports  audit tracking as the event occurs,  and stores computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Audit records are maintained on a historical basis unless purged or archived, Purging or Archive strategy is deployed in customer production environment based on Integrin best practices, and at least as long as required for the subject electronic records and shall be available for agency review and copying.

Integrin assigns a unique User Login for the user which is used as a electronic signature, and the User Login cannot be reused by, or reassigned to anyone else

 

 

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