Audit Readiness
Be inspection-ready at all times. Access complete compliance data across all your systems instantly, with audit trails that satisfy FDA and EU GMP requirements.
The inspection preparation challenge
When inspectors arrive, every minute counts. Scrambling across systems to find data creates stress and risk.
Searching multiple systems for documents, training records, and quality events.
Missing links between systems lead to observations and 483s.
Fragmented history across systems fails to tell the complete story.
Always inspection-ready
Compliance Dashboards
Real-time visibility into compliance status across all quality systems. Know your readiness at a glance.
- Document expiry tracking
- Training compliance status
- Open quality events
- Overdue CAPA alerts
Audit Trail Access
Unified audit trail spanning all connected systems. Every action, every change, fully traceable.
- Cross-system event history
- User action logging
- Change reason capture
- Electronic signature records
Report Generation
Generate inspection-ready reports on demand. Product histories, supplier records, training status in seconds.
- Product quality dossiers
- Supplier qualification packages
- CAPA summary reports
- Training matrices
Inspection Preparation
Proactive gap identification and remediation tracking. Address issues before inspectors find them.
- Pre-audit self-assessment
- Mock inspection mode
- Gap remediation tracking
- Inspection history
Built for regulatory compliance
BioWise is designed to meet the most stringent pharmaceutical regulatory requirements.
Electronic records and signatures compliance with full audit trail.
Computerized systems requirements for European market access.
Risk-based validation approach with IQ/OQ/PQ documentation.
Results you can expect
To inspector requests
All systems unified
Know issues first
Not just before audits
Be inspection-ready every day
See how BioWise provides complete compliance visibility across all your systems.
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