2.1.6.5 Product Acceptance Plan

Product Acceptance Plan describes how the customer will evaluate the deliverable artifacts from a project to determine if they meet a predefined set of acceptance criteria. It details these acceptance criteria and identifies the product acceptance tasks (including identification of the test cases that need to be developed) that will be carried out, and the assigned responsibilities and required resources.

We are doing validation and QA testing to determine whether automated classification is as good as, or better than, manual gating and will get acceptance from the customer. The challenge of the acceptance plan is how we determine when an automated method is better than manual gating for a whole assay or set of data, as opposed to one population from one sample.