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Phase Feasibility
Compilation and consideration of the following deliverables is recommended during this phase:
Requirements need to be compiled comprehensively on a product/ system level e.g. by using a content template.
Critical contents to be considered:
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(e.g. reagent onboard time variation, pipetting variation, sample stability)
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The requirements management plan defines the requirements process for a specific projects, including:
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The Master Validation Plan provides a breakdown into all V&V activities (see layer model below) for a product (platform & assays) with its components, including manufacturing.
This planning process will result in a hierarchy of V&V plans (see below).
The Configuration Management Plan contains definitions and descriptions of product configuration scope and release along the lifecycle.
The interfacing of platform versions with reagent lots is provided . The document plans the introduction of upcoming changes (design changes, obsolescence ...) in configurations.