Who Is This For?
Authors / Owners – Setting up and coordinating the CR
Reviewers – Validating scope and content
Approvers / QA – Ensuring compliance and authorizing steps
Admins – Configuring Entity Types and workflow rules
Managers – Monitoring status and readiness for closure
When is a Change Request required?
When is a Change Request required?
A CR is required when the document’s assigned Entity Type (i.e SOP, WI, Policy) is configured to mandate a CR. This rule is defined by an administrator during Entity Type setup.
💡 If you’re unsure whether a CR is required for a given document type, check the document’s Entity Type or ask your QA/Admin.
How the Change Request Workflow Works
Step 1: The three phases at a glance
Planning – Draft the CR, define scope, link controlled items, create Actions, and (if configured) send for Review/Approval.
Execution – Process all in-scope records (templates, quality documents), complete Actions, and update attachments/relations, and (if configured) send for Review/Approval.
Closure – Confirm effectiveness (if required), ensure final states (e.g., Effective/Closed), and complete documentation.
📎 Reference:
Step 2: Customize the change control workflow (Change Types)
Your organization can tailor Change Types to include/exclude review and approval in Planning and/or Execution, and to control what’s required before closure.
Actions can be made mandatory to complete before final approval.
Templates and documents processed under a CR typically remain Awaiting Release until the CR closes.
📝 Note: Workflow configuration impacts compliance. Changes to Change Types, states, and required steps should be performed by your QA/System Administrator.
📎 Reference: Configuring Change Control Settings
Step 3: Keep records linked for full traceability
Use the right linkage for the right purpose so compliance and tracking behave as expected.
Controlled items (in scope) – Records that must change under this CR (e.g., templates, quality documents). They are listed under Items to Change and are governed by the CR’s plan and approvals.
Related items (not in scope) – Helpful cross-links (e.g., meeting notes, other CRs, supporting materials). They do not change state under this CR.
Attachments – Evidence files (often external to the system) you want to store with the CR for context and audits. Attachments do not become controlled items.
📝 Note: Only controlled items are constrained by the CR workflow (e.g., cannot progress beyond certain states until the CR plan is approved). Related items and attachments are not controlled by the CR.
📎 Reference: Managing Attachments
Tips
💡 Align Change Types with your SOPs so Review/Approval/Effectiveness requirements are enforced.
💡 Use CR Actions to prevent final approval until all tasks are complete.
💡 Keep scope focused to simplify execution and verification.