Validatingcomputerizedsystem com

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The functional specifications describe the functions of the system and how it was built.

In the V-model, the functional specifications correspond to the operational qualifications, as each of the parameters should be tested.

Once the design is tested, and if it works as intended, then you have satisfied not only the function requirements, but the overall requirements for system use.

The rapid adoption of automation in life sciences is being driven by the fundamental need for greater consistency, reliability and efficiency in an increasingly dynamic and complex environment.Over time, GAMP has become the acknowledged expert body for addressing issues of computer system validation.GAMP's guidance approach defines a set of industry best practices to enable compliance to all current regulatory expectations.GAMP recommends an SDLC called the V-model (see graphic) because it is a commonly used design, but there are others that can be followed.The V-model shows how the three main qualification activities (installation, operation and performance) are linked back to the design process.

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