Individual System Specifications (Functional Specifications)
System Specifications represent the detailed path to achieve the User Requirements.
For each system, piece of equipment, or sub-project QPS will present for customer approval detailed documents specifying the system. It is critical in a regulated environment that the regulatory compliance office reviews and has input to these documents. Descriptions of specific equipment, space planning, utility connections, and process operations are to be found here. As much as possible, this is where the project is assembled on paper. Upon customer approval, the System Specifications document is subject to change control. Authorized individuals at QPS and the customer company must certify changes to the project, since these would probably change the project budget.
Between the User Requirements and the System Specifications, there is sufficient information to obtain financial estimates and price quotations as well as assemble a project plan (timeline) which includes both performance objectives and timing.
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