Equipment Readiness for Production

This workflow covers how equipment is managed in Clarix from initial registration through ongoing maintenance and the automated readiness checks that occur during batch step execution. Keeping calibrations and PMs current is a prerequisite for batch release under 503B standards.

Process overview

Step 1 — Register the asset

Role required: Equipment Manager, QA Officer

1. Navigate to Equipment → Asset Registry and click New Asset.
2. Enter the required fields:
   • Asset name and description
   • Manufacturer, model, and serial number
   • Asset tag / barcode (for scan-in during batch steps)
   • Location — room or area where the instrument is stationed
   • Criticality — Critical, Major, or Minor (affects scheduling defaults)
3. Upload the manufacturer's qualification documentation if available.
4. Save. The asset is now in Active status and visible throughout Clarix.

Step 2 — Configure calibration schedule

Role required: Equipment Manager

1. Open the asset and navigate to the Calibration tab.
2. Click Add Calibration Schedule and configure:
   • Frequency — e.g., every 6 months, annually
   • Calibration type — internal (performed in-house) or external (third-party vendor)
   • Next due date
   • Tolerance limits (if applicable for the instrument type)
3. Save. Clarix automatically creates the first upcoming calibration task and will generate subsequent tasks when each calibration is logged.
4. Instruments approaching their due date appear on the Equipment Dashboard and trigger notifications to the Equipment Manager.

Note: When a calibration is logged (internal or external), attach the calibration certificate. For external calibrations, the certificate from the accredited lab is required.

Step 3 — Configure PM schedule

Role required: Equipment Manager

1. On the same asset, navigate to the Preventive Maintenance tab.
2. Click Add PM Schedule and configure:
   • PM type — cleaning, lubrication, inspection, replacement
   • Frequency — daily, weekly, monthly, quarterly, etc.
   • Owner — the person or role responsible for performing the PM
   • Next due date
3. Clarix generates PM tasks at the configured interval and sends reminders to the assigned owner.
4. When a PM is completed, the technician logs it with a completion note and any parts replaced.

Step 4 — Log cleaning before use

Role required: Batch Technician, Equipment Technician

1. Navigate to Equipment → Cleaning Logs or access the cleaning log directly from the asset page.
2. Click Log Cleaning for the asset you are about to use in a batch.
3. Enter:
   • Cleaning agent used (selected from approved cleaning agent list)
   • Cleaned by (your name is pre-filled)
   • Date and time
   • Notes (any visual inspection observations)
4. Save. The cleaning log entry is timestamped and linked to the asset.
5. During batch step execution, Clarix can reference the most recent cleaning log for that asset.

Step 5 — Batch step execution with equipment

Role required: Batch Technician

1. During a batch step that involves instrumented measurements or equipment use:
   • Tap or click the Equipment field in the step.
   • Scan the asset barcode or search by asset name.
   • Clarix loads the asset details and checks calibration status in real time.
2. If the calibration is current, the asset is accepted and linked to the step. Proceed with the measurement.
3. If the calibration is overdue (see Step 6 below), the step is blocked.

Step 6 — Overdue calibration blocks step completion

Role required: Batch Technician, Equipment Manager

If Clarix detects that the assigned instrument has an overdue calibration when linked to a batch step:

1. A blocking alert is displayed on the step. The technician cannot mark the step complete.
2. The technician has two options:
   • Option A — Log calibration: The Equipment Manager logs the overdue calibration (or the external calibration certificate is uploaded), clearing the overdue flag. The technician can then re-link the asset and proceed.
   • Option B — Substitute asset: The technician selects an alternative, calibration-current asset. The substitution must be documented in the batch record as a GDP amendment with justification.
3. If neither option is available (no calibrated substitute, calibration cannot be performed immediately), the batch step cannot proceed until the equipment status is resolved.

Edge case: Document the equipment substitution as a batch amendment. The QA Officer will see the amendment during review and can raise a deviation if the substitution was not pre-approved by SOP.

Edge cases

Related pages

• Asset Registry
• Calibration
• Preventive Maintenance
• Cleaning Logs
• Executing Steps