Problem Reports

The Problem Reports workspace enables you and your team to capture all problem reports identified by your organization. Use a problem report to document, analyze, and resolve issues. When you create a problem report, you can describe, prioritize, and categorize it. The process involves an initial review and an optional technical analysis. You can also use a problem report to automatically derive a subsequent change request. They may be created by anyone with a Problem Reports [C] or Problem Reports [R/W] role.

Problem reports involve three stakeholders.

• The creator / owner of the report who provides all relevant details. This person is notified about the report’s progress automatically at defined transitions.
• A reviewer who will analyze the report within a defined time frame. The reviewer decides about next steps and may also request further details from the problem report creator / owner.
• A technician may be involved if there is a technical problem. This person provides feedback and may initiate a follow-up CAPA and or change request if required.