🧭 Course overview
After completing this training, you will understand how Change Requests are created, managed, and completed in SimplerQMS - and how they move through planning, execution, and approval in a controlled workflow.
The course contains the following chapters:
Why - why controlled change is critical in regulated environments
Basics - understand the Change Request lifecycle and key building blocks
How-to - see how Change Requests are handled in SimplerQMS from start to finish
🎓 Learning objective: Get a clear, practical understanding of Change Management - and learn how to create, process, and complete Change Requests in SimplerQMS in a controlled and compliant way.
⏱ Training duration: 15 min.
🎯 Target group: QA, document controllers, process owners, and anyone involved in creating, reviewing, or approving changes in SimplerQMS
1. WHY: Change Management (Read: 3 min)
In life-science companies, not all changes are equal -
Even a small update to a document, process, or template can impact compliance, product quality, or patient safety. That’s why changes must be controlled, reviewed, and approved before they are implemented.
Change Management in SimplerQMS ensures that every change is handled in a structured way - from request to execution to final approval - with full traceability at every step.
1.1 Why change management matters
In the life-science industry, nothing stays static - processes evolve, documents get updated, equipment changes, and systems are improved. But every change, no matter how small, can affect quality, compliance, or patient safety.
That’s why regulatory bodies require organizations to control how changes are proposed, reviewed, approved, and implemented.
Change Management ensures that no update is made without understanding its impact and ensuring the right people have reviewed and approved it first.
Changes can include:
A document update (e.g., revising an SOP after repeated audit findings)
A process change (e.g., adding a mandatory QA impact assessment step)
A template change (e.g., adding a second-person verification to a release form
A product change (e.g., updating product specifications or release criteria)
Good Change Management isn’t slowing things down.
It’s making sure every change is intentional, assessed, and traceable. And most importantly - it protects your compliance and your product quality.
1.2 Regulatory foundation (High-level)
Regulations such as:
Require organizations to ensure that all changes are controlled, assessed, and documented before implementation, so that the impact on quality, compliance, and patient safety is always understood and approved in advance.
This typically means:
Formal change control process
No change is implemented informally or “on the fly” without evaluation of impact and risk (e.g., updating a deviation workflow only after a documented Change Request has been approved).
Impact and risk assessment
Potential effects on product quality, validated systems, and regulatory compliance are identified before the change is executed (e.g., assessing whether adding a new QA approval step affects batch release timelines or validation status).
Traceability of change history
It is always possible to see what changed, why it changed, who approved it, and when it was implemented (e.g., linking a revised SOP version to its originating Change Request).
Evidence of completion and effectiveness
Organizations can demonstrate that changes were properly implemented and verified as effective (e.g., confirming that updated training records or revised procedures are in use after release).
Change control is therefore not just an internal process step - it is a regulatory expectation that ensures control, accountability, and patient safety across the entire lifecycle of a change.
2. BASICS: Change Management (Video: 4 min)
2.1 The basic elements
Change Management in SimplerQMS connects controlled items, structured change requests, assigned roles, and workflow steps - ensuring every change is assessed, approved, implemented, and verified before it becomes effective.
What a Change Request includes in SimplerQMS
A Change Request in SimplerQMS brings together all the information needed to control, assess, and approve a change before it is implemented.
Controlled Items (Documents / Templates)
The items that are directly affected by the change. These are linked to the CR to clearly define what is being updated, such as SOPs, work instructions, forms, or templates.
Attachments
Additional documentation that supports the change rationale, such as impact assessments, validation evidence, or reference documents.
Actions (Tasks linked to the change)
Optional structured tasks that break the change into clear steps. Actions ensure accountability and help track completion of required work before approval.
These elements work together to ensure that documents are always accurate, controlled, and audit-ready.
3. HOW-TO: Change Management (Video: 6 min)
3.1 Step-by-step guide to do it yourself
After watching the video or going through the steps below, you can now manage Change Requests in SimplerQMS.
Step 1: Plan the Change
Create and draft the Change Request (CR). Define the reason for the change, affected items, required updates, responsibilities, and any planned actions before implementation begins.
Step 2: Review and/or Approve the Change Plan
If required based on the type of change, send the Change Request plan for review and/or approval to confirm the proposed change is appropriate, assessed, and ready for execution.
Step 3: Execute the Change
Carry out all planned updates linked to the Change Request, including document revisions, template updates, assigned actions, and related activities.
Step 4: Final Review and/or Approval of the Change
Once execution is completed, route the Change Request for final review and/or approval to confirm the change was fully implemented and documented correctly before release.
Step 5: Check if the Change is Effective
After implementation, verify that the change achieved the intended outcome and did not introduce unexpected issues or compliance risks.
Step 6: Check Effectiveness
After implementation, verify that the change achieved the intended outcome and did not introduce unexpected issues.
If the Change is Not Effective
If the Change Request is determined to be not effective, the system automatically prompts to create a new Change Request to address the issues identified during the effectiveness review of the original CR.
3.2 Practical tips
💡Define the purpose of the change clearly
Make sure the Change Request clearly explains why the change is needed, what problem it solves, and what outcome is expected before approval.
💡Assign clear ownership and ensure complete impact coverage
Make sure all affected items are linked and each action has a responsible owner so nothing is missed and execution is properly tracked.
💡Confirm effectiveness after implementation
Verify that the change achieved its intended outcome and did not introduce new issues or compliance risks. If it is not effective, a follow-up Change Request should be created.
3.3 More detailed information in the Help Center
For more guidance on Change Requests, check our step-by-step Change Management manual in the help center.