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Specification Document
Validation is the process of providing documented evidence that equipment, systems and processes are installed, operate and perform as specified. The process of providing the necessary documented evidence is most commonly accomplished through the development of two different but complimentary groups of documents: specification documents and validation protocols.

Specification documents define how the equipment or system should be installed and operate, and how the equipment or system should perform during regular use in its normal operating environment. The wide variety of specifications required to clearly define the installation, operation and performance are most often grouped into the following specifications; a Design Specification, a Functional Specification and a User Requirement Specification. Each of these documents provides the foundation to support validation protocols.