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Verification is intended to check that a product, service, or system meets a set of design specifications. [6] [7] In the development phase, verification procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service, or system, then performing a review or analysis of the modeling results.
Examples of artifact validation: User Requirements Specification validation: User requirements as stated in a document called User Requirements Specification are validated by checking if they indeed represent the will and goals of the stakeholders.
The Validation Master Plan is a document that describes how and when the validation program will be executed in a facility. Even though it is not mandatory, it is the document that outlines the principles involved in the qualification of a facility, defines the areas and systems to be validated and provides a written program for achieving and ...
Test coverage in the test plan states what requirements will be verified during what stages of the product life. Test coverage is derived from design specifications and other requirements, such as safety standards or regulatory codes, where each requirement or specification of the design ideally will have one or more corresponding means of verification.
A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP (Good manufacturing practice) regulated pharmaceutical industry as it drives a structured approach to validation ...
Verification and validation of computer simulation models is conducted during the development of a simulation model with the ultimate goal of producing an accurate and credible model. [ 1 ] [ 2 ] "Simulation models are increasingly being used to solve problems and to aid in decision-making.
In the prototyping stage, engineers create actual working samples of the product they plan to produce. Engineering verification testing (EVT) is used on prototypes to verify that the design meets pre-determined specifications and design goals.
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.