Gabarit - Qualification and Validation Templates

Gabarit - Qualification and Validation Templates

Documents

Process Validation - Validation de procédé Process Validation - Validation de procédé

Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.

Factory Acceptance Test (FAT) Factory Acceptance Test (FAT)

The protocol describes all Factory Acceptance testing that are necessary to verify the conformity with the customer’s specifications (performance and design) prior to installation on site.

Computer Commissioning Protocol Computer Commissioning Protocol

The Commissioning is the process by which an application, equipment, system, facility, or plant (which is installed, or is complete or near completion) is tested to verify if it functions according to its design objectives or specifications.

The protocol describes all Commissioning (CP) testing that are necessary to verify the conformity with the customer’s specifications. It determines the tests to be performed and the corresponding test to execute.

Equipment/System Commissioning Protocol Equipment/System Commissioning Protocol

The protocol describes all Commissioning testing that are necessary to verify the conformity with the customer’s specifications.

User Requirement Specifications User Requirement Specifications

This document encompasses the normal range of equipment operations. This section should be expanded to provide a high level description of the system explaining why it is required and what is required of it.