This document outlines an optimized validation model for configurable off-the-shelf products. It involves executing test scripts and documenting any deviations during performance qualification, operation qualification, and installation qualification stages to validate the product meets requirements. Infrastructure qualification scripts may also be run depending on whether the offering is hosted or on-premises. The model is driven by both user requirements and vendor base product configurations.

1. V Model for COTs ‐ Optimised Validation
User Driven
PQ Execute Scripts, Deviation
Project Management
SOP
Conf. Spec
URS
PQ Scripts RTM
URS
Base Product OQ Scripts1 * Execute Scripts, Deviations & RTM
Client Conf. Spec OQ Scripts
IT Driven
Application IQ Execute Scripts & Deviation
Product IQ Plan & Scripts
Infrastructure IQ Plan & Scripts2 Infrastructure IQ Execute Scripts & Deviation
Plan
Client
Vendor
COTs = Configurable of the Shelf 1 Only Configurations specifically set for <Client> are tested.
URS = User Requirement Specification All base functionality and configurations as out of box
IQ = Installation Qualification
should have been tested by the Vendor and
OQ = Operation Qualification
PQ = Performance Qualification documentation available on request or at audit.
RTM = Requirement Traceability Matrix 2 If SaaS (Software as a Service) offering then vendor will
SOP = Standard Operating Procedure provide these.