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Short note on Verification and Validation process.
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  • Verification is intended to check that a product, service, or system (or portion thereof, or set thereof) meets a set of design specifications.

  • 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 modelling results.

  • In the post-development phase, verification procedures involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses.

  • It is a process that is used to evaluate whether a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.

  • Validation is intended to ensure a product, service, or system (or portion thereof, or set thereof) result in a product, service, or system (or portion thereof, or set thereof) that meets the operational needs of the user.

  • For a new development flow or verification flow, validation procedures may involve modelling either flow and using simulations to predict faults or gaps that might lead to invalid or incomplete verification or development of a product, service, or system (or portion thereof, or set thereof).

  • A set of validation requirements (as defined by the user), specifications, and regulations may then be used as a basis for qualifying a development flow or verification flow for a product, service, or system (or portion thereof, or set thereof).

  • Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow or verification flow will have the effect of producing a product, service, or system (or portion thereof, or set thereof) that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified. It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements.

  • This often involves acceptance of fitness for purpose with end users and other product stakeholders. This is often an external process.It is sometimes said that validation can be expressed by the query "Are you building the right thing? and verification by "Are you building it right?".

  • "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.It is entirely possible that a product passes when verified but fails when validated. This can happen when, say, a product is built as per the specifications but the specifications themselves fail to address the user’s need.

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