Auditing and Survey Software
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.
- Configurable surveys.
- Helpful tips.
- Reports and dashboards.
Data Integrity Audit Management
- Create system inventory
- Assign each system to owner
- Have owner update status and complete data integrity audit questionnaire
- Track status
Reporting and Tracking
- Email notifications on system updates
- Role-based reporting
21 CFR Part 11 Compliance
- Audit trail records the date, time, user ID, type of action and other details
- Role-based assignment of security security rights, privileges and roles
- Configure actions that require electronic signatures
- Password Aging forces a new password after a configurable period
- Account lockouts after a configurable number of retries
- Automatic Session time-outs