Data integrity audits based on FDA guidance
Integpro lets quality heads, department heads and system owners see compliance status at a glance, find gaps and take corrective action. It works for a single department or a corporate data integrity initiative.
Benefits
- Configurable surveys.
- Built-in tips guide system owners.
- Reports and dashboards.
- Email notification on system updates.
- Part 11 compliant, paperless tracking.
Features
Inventory and Ownership
Every system has an owner.
- Inventory: Create a system inventory.
- Owners: Assign each system to an owner.
- Questionnaire: Owners complete a data integrity audit questionnaire.
- Status: Track progress across systems.
Reporting and Tracking
Status at a glance.
- Notifications: Email on system updates.
- Reports: Role-based reporting.
- Dashboards: See compliance status across systems.
Part 11 Compliance
Controls built in.
- Audit trail: Date, time, user ID and action type.
- E-signatures: Configurable actions that require signing.
- Access: Role-based rights, password aging, lockout and session time-outs.
Integpro Brochure Download
Auditing and survey software for data integrity risk assessments, based on FDA guidance.
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