Modules
Batch Records
Digital batch record management for sterile compounding
Batch Records
The core module of Clarix — digital batch records replace paper-based manufacturing records with guided, step-by-step execution workflows.
Workflow
Draft <Icon name="ArrowRight" size={12} /> Scheduled <Icon name="ArrowRight" size={12} /> In Progress <Icon name="ArrowRight" size={12} /> Pending Review <Icon name="ArrowRight" size={12} /> Pending Release <Icon name="ArrowRight" size={12} /> ReleasedKey Features
- Step-by-step execution — Technicians follow guided workflows on iPad
- Real-time tracking — Production managers see live batch status
- E-signatures — Every critical step requires authenticated signatures
- Barcode scanning — Component verification via barcode scan; lots with barcodes must match at issue
- Keyboard-wedge scales — Weight-type steps capture manual entry or USB HID wedge with stable-read UX
- Tolerance checking — Auto-flag out-of-spec measurements
- Deviation linking — Connect issues directly to batch records
- BUD calculation — Automatic beyond-use date based on formula
Business Rules
| Rule | Description |
|---|---|
| B1 | All required components must have lot_status = 'released' |
| B2 | Steps execute in order — step N+1 blocked until step N completes |
| B3 | Signature-required steps block progression until captured |
| B4 | Witness-required steps need a second user's signature |
| B6 | Out-of-tolerance values auto-flag and prompt deviation creation |
| B7 | Only QA Manager can transition pending_review <Icon name="ArrowRight" size={12} /> pending_release |
| B8 | Only PIC can transition pending_release <Icon name="ArrowRight" size={12} /> released |