Quality Management
Stop disconnected quality systems.
Embed quality into every step. Manage specifications, test results (LIMS), deviations, CAPAs, and change controls in the same system where you manufacture. Release batches faster with exception-based review.
Capabilities
Everything you need
Integrated LIMS
Sample tracking, test assignments, and result entry with specification checking.
Deviation Management
Capture deviations in context. Root cause investigation. Link to affected batches.
CAPA Workflow
Corrective and preventive actions with effectiveness verification.
Change Control
Track changes with impact analysis. Approval workflows. Implementation tracking.
Supplier Quality
Vendor qualification, audits, and approved supplier lists.
Stability Studies
Real-time stability tracking with automated sampling schedules.
Exception-Based Release
Don't review empty checkboxes. The system highlights only the exceptions—OOS results, deviations, or alarms—so QA focuses on what matters. Normal batches release in minutes, not days.
- Focus QA time on real issues
- Reduce review time by 70%
- Faster batch release
- Complete audit trail
Exception-Based Release
Built into Helix OS core
Use Cases
Built for real workflows
Batch Release
Exception-based QA review with all batch data, deviations, and test results in one view.
Out-of-Spec Investigations
Structured OOS workflow with root cause analysis and CAPA linkage.
Annual Product Review
Automated data aggregation for APR with trend analysis.
See Quality Management in action
30 minutes. No slides. Just the product. See how quality management can transform your operations.