Definition phase

The first step of this phase is a definition of all the needs; these are often formulated by the future user, in the form of a document called the user requirement specification (URS). Since the user is often not a computer specialist, the URS is typically written in a non-technical way. It is, however, crucial that the needs are expressed in detail and, if possible, in a quantitative way, so that they can later be verified during the qualification phase. The user should also highlight the criticality, with respect to the process or product, of each requirement. For instance in cell culture, the effects

Validation master plan

Validation report

Qualification

Development and construction

Figure 13.7 Example of a V-shaped validation diagram for a computer system. Double arrows indicate the links between the steps of the definition and design phases, and the corresponding tests of the qualification phase. Diamonds represent milestones. (For the meaning of abbreviations, see main text.)

FATs

HDS

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Development and construction

Figure 13.7 Example of a V-shaped validation diagram for a computer system. Double arrows indicate the links between the steps of the definition and design phases, and the corresponding tests of the qualification phase. Diamonds represent milestones. (For the meaning of abbreviations, see main text.)

FATs

(technical, regulatory, economic, etc.) of inaccurate control of some parameters or of a temporary failure of the supervision tool should be clearly described. This can greatly help the work of developers as well as providing a base for risk analysis, which is performed later to determine the required level of qualification and testing.

In a second step, a functional analysis is performed to analyse and describe in detail each requirement of the URS and to break it down into elemental functions or functional specifications (FS). The result is usually a much more technical description of the system (hardware and software) to be developed.

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