Calibrated test equipment (external and internal) is defined by test equipment classes.
test equipment class 1 (external calibration every XY years)
test equipment class 2 (internal inspection every year)
test equipment class 3 (no calibration needed)
All instruments and instrument components are checked for their functional efficiency. Functional Tests are accomplished during production for:
printed boards,
dosing and dispersing units after assembling, and
outsourced items after assembling.

Figure: SOPs for the functional tests (Operational Qualification) of a vacuum extracion unit.
|
Basis |
| SOP's |
| Life Cycle Model |
| Reference Materials |
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|
Quality results |
| 21 CFR Rule 11 |
|
Support |
| Validation |
|
Information |
| Publications |
| ISO standards |