Equipment Validation Checklist
This page is under construction. This checklist, when completed, shall provide guidance on what test cases would be needed with particular equipment.
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Classification (Internal)
This section is not always utilized by companies. Classification, however, allows the definitions of requirements within the validation SOPs. Listed are samples of what might be used to classify |
I | Simple, no electronic parts, no moving parts |
| Ib | critical part, no electronic or moving parts | |
| II | moving parts, no electronic parts | |
| IIb | critical part, moving, no electronics | |
| III | simple electronic parts | |
| IIIb | critical part, simple electronics | |
| IV | firmware | |
| IVb | Critical part, firmware | |
| V | software |
| Required (R) | |||||||||
| May not be Required (MN) | |||||||||
| Conditionally Required (CR | (Internal Products) | ||||||||
| Not Required | |||||||||
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Test Cases
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Category | ||||||||
| I | II | III | IV | V | VI | VII | VIII | ||
| IQ | System Instrumentation | (R) | (R) | (R) | (R) | (R) | (R) | (R) | (R) |
| Component Verification | (R) | (R) | (R) | (R) | (R) | (R) | (R) | (R) | |
| Auxiliary Equipment Verification | (R) | (R) | (R) | (R) | (R) | (R) | (R) | (R) | |
| Manuals | (R) | (R) | (R) | (R) | (R) | (R) | (R) | (R) | |
| Technical Documents | |||||||||
| Design Documentation | |||||||||
| Factory Calibration | |||||||||
| Factory Inspection | |||||||||
| Composition Verification | |||||||||
| Blueprints/Drawing/Schematics | |||||||||
| Associated Materials/Resources List | |||||||||
| Safety Requirements List | |||||||||
| Spare Parts Lists | |||||||||
| Nameplate | |||||||||
| Physical Installation | |||||||||
| Utilities Verification | |||||||||
| Environmental Requirements |
Temp/Humidity usually required
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| Materials/Composition Verification | |||||||||