Example: validation plan according to the retrospective model procedure |
|
Project Phase
Elaborations |
Activity/ Document
|
Support through
|
| Securing the running operation: Setting up a regulated operating status; freezing the status-quo. |
Operating instructions |
GTI
|
| System-related SOPs |
GTI
|
|
|
Quality assessment: |
Definition of requirements |
GTI
|
| Specification book |
GTI
|
|
| Documentation inventory: Compilation of all existing quality documents. |
Diverse |
GTI
|
| Setting up validation plan: Defining the individual measures. |
Validation plan |
GTI
|
| Field report |
---
|
|
|
Post-documentation: |
Technical specification |
System supplier / GTI
|
| Functional specification |
System supplier / GTI
|
|
| Design specification |
System supplier / GTI
|
|
| Risk analysis |
System supplier / GTI
|
|
| Installation protocols |
System supplier / GTI
|
|
| User manual |
System supplier / GTI
|
|
| Installation qualification (IQ) |
GTI
|
|
|
Tests: |
Test specifications |
GTI
|
| Functional qualification (OQ) |
GTI
|
|
| Performance qualification (PQ) |
GTI
|
|
| Release: Reintroduction of the system into productive operation in the target environment. |
Validation report |
GTI
|

