Extract of SOLABS' provided Validation Plan:
Computer System Validation is a documented process for ensuring that GxP computerized systems are suitable for intended use and function according to predefined quality attributes.
The purpose of this Validation Plan (VP) is to establish the overarching validation strategy for the SOLABS QM System and to define the required validation activities appropriate for the identified scope of this project.
Our Validation Plan defines the validation strategy and required deliverables for the initial implementation of SOLABS QM, and thus, should be consulted during the development of subordinate validation protocols, associated documents, and during the execution of any validation activity related to the SOLABS System.
A summary of validation deliverables are listed in the SOLABS QM Validation Documentation Index (INDEX-SOL-001). SOLABS QM Validation Package
The Validation Plan covers the validation of the SOLABS QM software system and of each one of its extensions (e.g. new processes or system upgrades). In other words, it can be considered as a Validation Plan for SOLABS QM to remain in a validated state throughout its life cycle....