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Operational Hub

End-to-end QC operations, connected and audit-ready

From batch release to deviations, CAPAs, and change requests. All workflows in one system, linked to the batches they affect.

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Operational Hub

Modules

The full QC workflow in one place

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Batch Release

Oversee and manage end-to-end batch release. Track status across all open batches and coordinate approvals.

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Batch Record Review

Checklist-driven review with digital sign-off. Linked to open items and deviations. Full audit trail included.

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QC

Sample management, test assignments, and results tracking for your QC lab.

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Deviation

Log, investigate and close deviations, linked directly to affected batches and CAPAs.

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Investigation

Root cause analysis workflows for OOS results and process deviations.

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CAPA

Manage corrective and preventive actions end-to-end, from assignment to effectiveness check.

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Change Request

Controlled change management with impact assessment and approval workflows.

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MODA

Market deviation and OOS data management, structured and audit-ready.

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Planning

Capacity planning for QC workloads. Balance analyst availability against incoming sample volume.

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Reports

Operational reports for batch release, QC throughput, deviations, and more.

Feature Details

What you get

All batch workflows in one place

Batch release, record review, QC, deviations are all connected. No switching between systems, no duplicated data entry.

All batch workflows in one place

Linked across the release process

Deviations link to batches. CAPAs link to deviations. Every workflow feeds into the full picture, so nothing gets missed.

Linked across the release process

Built for regulated environments

Digital sign-off with full audit trail. Structured for GxP compliance and ready for inspection at any point in time.

Built for regulated environments

Explore the full platform

Operational Hub is one part of the q_alizer ecosystem. Explore the other hubs.

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