Pharmaceuticals
Quality systems expect every measurement that touches the product to be calibrated, recorded and reviewed.
What gets calibrated
- Temperature in rooms, autoclaves and stability chambers
- Pressure differentials between rooms
- Process pressure and flow
- Balances and gauges in utilities
What goes wrong without a record
A calibration done with an out-of-date reference, or approved by the person who did it, is a finding waiting to happen.
How Calibrator helps
- A calibrator with an expired certificate cannot be used: the database refuses it.
- The two-person rule: the approver is never the person who calibrated.
- Every change is in an audit trail that cannot be edited.
