While the Ketryx organization does not prescribe specific practices for managing your Quality Management System (QMS), we can offer guidance on typical uses of Change Requests (CRs). The approach to managing CRs, along with the resulting requirements and specifications, ultimately depends on the judgment of your quality assurance department.

A more traditional approach involves obtaining approval for the resulting requirements and specifications before initiating work on a CR. If there are any changes to the CR, the tickets would need to be reopened and closed again.

Alternatively, a less traditional, but more common approach involves ensuring that CRs, requirements, specifications, code, and tests are all aligned and approved simultaneously. Consistency is crucial during the CR implementation process, requiring your team to diligently verify related configuration items. In this scenario, records would remain open until a final review confirms that everything is in order.

Ultimately, the choice of approach depends on your organization's risk tolerance and quality assurance standards.