Regulatory Lifecycle

The regulatory lifecycle is enabled in the regulatory document library to ensure standardized processing.

The lifecycle contains the following stages:

  • Draft
  • In Content Review
  • In Regulatory Review
  • In Approval
  • Submission Ready

When a document is created, it is stored into the regulatory documents library with the lifecycle status of Draft and version of 0.1. This is the authoring stage of the document’s lifecycle.

The In Content Review stage is the stage where the reviewers review the content to ensure that the content is accurate and complete.

The In Regulatory Review stage allows a regulatory administrator to review the format and determine if the document meets regulatory standards.

The In Approval stage is the stage where a document that is reviewed for content and format is submitted for approval. If the document is approved, it will automatically be transitioned to the Submission Ready stage.