ABSTRACT
This chapter covers the product requirements activities. A requirement is a need or expectation that is stated, generally implied or obligatory. "Generally implied" means that it is common practice for the relevant stakeholder such that its absence would be deemed an obvious shortcoming. The term "requirement" defines a bounded characterization of the system scope that can be generated by different relevant stakeholders. Requirements management is the process of documenting, analyzing, assessing the risk, tracing, prioritizing and agreeing on requirements, and then controlling change and communicating to relevant stakeholders. The Quality System regulation requires a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The main deliverable after getting the commitment of the relevant stakeholders is the requirements specification (RS). The RS must include an overview of the process in order to familiarize the infrastructure and application developers with the regulated user, business process, regulatory and data acquisition requirements of the system, and any special considerations for the project.
