http://www.gti-tech.de/gti-tech/English/pages/Produkte/Validierungsplan1.php

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:
System check as to the fulfilment of the GMP standards; definition of the requirements as to design and functionality.

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
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Post-documentation:
Implementation of the requirement in a detailed description of the system;
definition of hardware environment;
definition of software environment, description of interfaces.

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:
Functional test; interface test;
system test.

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