IntegPro is a purpose-built solution designed to help you perform risk assessments of all your company’s systems in order to track, prioritize and manage your company’s compliance status. Based on FDA’s guidance on data integrity, the software allows heads of quality, departmental heads and system owners to know their data integrity compliance status at a glance, understand the compliance gaps, and help take remedial action.
IntegPro is fully compliant with 21 CFR Part 11 requirements and hence can be used for paperless tracking and management of data integrity status.
The software is designed to be used by departments or as part of a corporate initiative for data integrity compliance.
Electronic Records and Audit Trail
- Stores all user actions in an audit trail with timestamp, user ID, action performed and other fields as applicable.
Administrator Audit Trail:
- Stores all administrator actions such as e-signature configurations, reason field assignments, user management, and user privileges.
Configurable Reason Fields:
- Set to optional or required based on object/action combination.
- Create e-signature templates defining the operations that require e-signatures
Configurable E-Signature Assignment:
- Different templates can be applied to different actions for unlimited flexibility and control.
- Define meanings (roles) for e-signatures and restrict user authority for e-signatures to specific roles.
Protection of Data:
- Data is stored securely in the system database.
Role based Assignment:
- Assign roles like System Owner, Department Manager, and System Administrator to each user.
Role Based Access:
- Different security templates can be applied to different roles for unprecedented flexibility and control.
- Force a new password after a configurable amount of time.
- Lockout the account after a configurable number of retries.
- Logout from the application after a configurable session time-out period.