Background information

Polarion supports a process of review and approval of individual Work Items, such as requirements. These may be contained in Documents, or created directly in the Work Item Tracker. For more information, see Reviewing and Approving Work Items). However, it can be desirable, for regulatory compliance and other reasons, to have such a process for entire Documents, such as requirements or design specifications.

Polarion can support your formal review and sign-off process for specifications and other types of LiveDoc Documents, using secure electronic signatures compliant with U.S. 21 CFR Part 11. A Polarion administrator can map your review and sign-off process to the Document workflow configuration. Each step in the process can optionally be set up to require one or more electronic signatures before the a Document can move to the next stage in the workflow.

Consider a simple example. Suppose a requirements specification Document goes through three stages before the requirements can be implemented in production: Draft, In Review, and Approved. An administrator can map these status values in the project workflow configuration for Documents of the type Requirements Specification. It is possible to configure as many Document types as you need. You might have more granular types like System Requirements Specification, Functional Requirements Specification, and types like Risk Analysis. The Document owner or manager can invoke actions to move the Document through the process from one status to the next. These status values can also be defined in the Document workflow configuration, and could be something like:

• Send to Review — This action transitions the specification Document from the Draft status to the In Review status.

• Mark Approved — This action transitions the specification Document from the In Review status to the Approved status.