Feasibility - Your Ideas Consulting

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:

- Optimized customer workflows with material- and infromation flows based on the automation level/ reagent kit design



- Instrument process with steps, parameters and error budgets to be executed per sample on the instrument



- Refinement of customer workflows into use cases (sub workflows)




- Identification of variation factors (error budgets) for component attributes with influence on product performance
 (e.g. reagent onboard time variation, pipetting variation, sample stability)




- Througput calculations
- Platform configurations to be sold to customers


The requirements management plan defines the requirements process for a specific projects, including:
- team organization
- requirements document structure with traceability and V&V layers (see below)
- interface to risk mangement process (se below)
- links into respective vendor documentation
- defines attribute use
- change control process and deliverables
- tool use




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.