Operational Hub
From batch release to deviations, CAPAs, and change requests. All workflows in one system, linked to the batches they affect.
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Modules
Oversee and manage end-to-end batch release. Track status across all open batches and coordinate approvals.
Checklist-driven review with digital sign-off. Linked to open items and deviations. Full audit trail included.
Sample management, test assignments, and results tracking for your QC lab.
Log, investigate and close deviations, linked directly to affected batches and CAPAs.
Root cause analysis workflows for OOS results and process deviations.
Manage corrective and preventive actions end-to-end, from assignment to effectiveness check.
Controlled change management with impact assessment and approval workflows.
Market deviation and OOS data management, structured and audit-ready.
Capacity planning for QC workloads. Balance analyst availability against incoming sample volume.
Operational reports for batch release, QC throughput, deviations, and more.
Feature Details
Batch release, record review, QC, deviations are all connected. No switching between systems, no duplicated data entry.
Deviations link to batches. CAPAs link to deviations. Every workflow feeds into the full picture, so nothing gets missed.
Digital sign-off with full audit trail. Structured for GxP compliance and ready for inspection at any point in time.