Integpro Risk Assessment System

The Integpro Risk Assessment System is a specialized software solution designed to assist organizations in performing risk assessments across all company systems. It facilitates tracking, prioritizing, and managing compliance status in line with FDA's guidelines on data integrity. This system is particularly useful for heads of quality, departmental leaders, and system owners, enabling them to quickly assess their data integrity compliance status, identify gaps, and implement corrective actions.

Integpro is fully compliant with 21 CFR Part 11 requirements, supporting paperless tracking and management of data integrity statuses. The software is versatile, allowing it to be utilized by individual departments or as part of broader corporate data integrity initiatives.

Benefits

• Configurable surveys tailored to organizational needs.
• Access to helpful tips for optimal use.
• Comprehensive reports and dashboards for quick insights.

Features

Data Integrity Audit Management

• Create and maintain a comprehensive system inventory.
• Assign systems to responsible owners who update status and complete data integrity audit questionnaires.
• Efficiently track the compliance status of various systems.

Reporting and Tracking

• Email notifications to keep users informed of system updates.
• Role-based reporting to ensure relevant insights are targeted to the appropriate users.

21 CFR Part 11 Compliance

• Detailed audit trail documenting date, time, user ID, type of action, and other essential details.
• Role-based assignment of security rights, privileges, and roles to enhance data security.
• Configurable actions requiring electronic signatures.
• Password aging policies to enforce password changes after a set period.
• Account lockouts after a specified number of failed login attempts.
• Automatic session timeouts to prevent unauthorized access.