Integpro Risk Assessment System

Data integrity risk assessment and audit tracking for 21 CFR Part 11 compliance.

Overview

Integpro Risk Assessment System, developed by CIMCON Software, is a purpose-built auditing and survey solution designed to help life sciences organizations perform comprehensive risk assessments across all company systems. It enables heads of quality, departmental heads, and system owners to track, prioritize, and manage their organization's data integrity compliance status — all based on FDA's guidance on data integrity. With a clear, at-a-glance view of compliance gaps and remedial action pathways, Integpro is suitable for use at the departmental level or as part of a broader corporate data integrity initiative.

Integpro is fully compliant with 21 CFR Part 11 requirements, making it a validated solution for paperless tracking and management of data integrity status across regulated environments.

Data Integrity Audit Management

Create and maintain a comprehensive system inventory across the organization
Assign each system to a designated system owner
Enable system owners to update status and complete data integrity audit questionnaires
Track the compliance status of all systems in real time

Reporting and Tracking

Automated email notifications triggered by system updates
Role-based reporting to ensure stakeholders receive relevant compliance information
Configurable surveys tailored to organizational needs
Built-in helpful tips to guide users through the assessment process
Reports and dashboards providing an at-a-glance view of overall compliance status

21 CFR Part 11 Compliance Features

Full audit trail capturing date, time, user ID, type of action, and additional details for every record
Role-based assignment of security rights, privileges, and user roles
Configurable electronic signature requirements for designated actions
Password aging functionality that enforces new passwords after a configurable period
Account lockout mechanisms triggered after a configurable number of failed login attempts
Automatic session time-outs to prevent unauthorized access

Integpro is part of CIMCON Software's Enterprise Series and is designed to support both departmental and enterprise-wide deployment, providing a scalable, compliant framework for managing data integrity risk assessments in regulated industries.