Example: Validation plan according to the prospective model procedure |
 |
|
Project Phase
|
Activity/ Document
|
Support through
|
| Planning / definition | Master validation plan |
GTI
|
| SOPs for validating computer-aided systems |
GTI
|
|
| User requirement specification (by customer) |
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|
|
| Functional specification (by system supplier) |
GTI
|
|
| Project validation plan |
GTI
|
|
| Specification | Hardware design specification |
System supplier /
GTI |
| Software design specification |
System supplier /
GTI |
|
|
Module design specification |
System supplier /
GTI |
|
| Design qualification (DQ) |
GTI
|
|
| Risk analysis |
System supplier /
GTI |
|
| Implementation and test |
Factory Acceptance Test (FAT) |
System
supplier /
GTI |
| Installation |
System supplier
|
|
| Siteacceptance test (SAT) |
GTI
|
|
| Start-up | Training schedule |
GTI
|
| Training measures |
System
supplier /
GTI |
|
| Installation qualification (IQ) |
GTI
|
|
| Operational qualification (OQ) |
GTI
|
|
| Performance
qualification(PQ) |
GTI
|
|
| Running operation | Service plan |
GTI
|
| Release Productive operation |
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|
|
| Modification management Change control Version tracking |
GTI
|