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. These are 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.

Installation Qualification, Operational Qualification and Performance Qualification protocols in turn, provide a series of tests and results that support the conclusion that the equipment or systems meet the requirements defined in the Design, Functional and User Requirement Specification. A robust validation protocol will contain an explanation of the validation approach and methodology, step by step test procedures and clearly defined, pre-approved acceptance criteria which traces directly to the specification documents, as well as clearly recorded supporting data.

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