Who Is This For?
CR Owners / Planners – initiating and documenting the effectiveness check
QA / Approvers – reviewing outcomes and ensuring compliance evidence is complete
Process / Document Owners – providing data and verification inputs for the assessment
How to Do It?
Effectiveness checks are performed after the CR is Closed.
Use the search bar or sort by ID, Title, State, or Last Modified to locate the record.
In the Properties card, select Effectiveness Check at the bottom, or open the Effectiveness Check tab.
Complete the form with the required information and click Submit Evaluation to finalize.
Select Save Draft if you need to return and complete it later.
Select Approve and Sign then enter the SimplerQMS log-in and password to provide the electronic signature.
💡 Tip: If the change was not effective, The system automatically asks the user to submit a new Change Request to address the problems found during the original CR's effectiveness review if it is found to be ineffective.
Tips
💡 Use measurable indicators (e.g., CAPA metrics, deviation rates, turnaround time) to support the effectiveness conclusion.
💡 Save as Draft if you are still gathering objective evidence; submit only when complete.