Management of Change
Modernize Change Management with Trackmedium eQMS
Trackmedium's eQMS Management of Change module helps you manage change across documents, equipment, suppliers, processes, and products. With configurable workflows, action plans, and real-time tracking, you can ensure each change is evaluated, approved, implemented, and verified with full visibility and traceability.
Standardized Change Workflows
Enforce consistency with configurable routing and role-based approvals.
Implementation Action Plans
Define and assign action items with deadlines and optional verification steps.
Impact and Risk Assessment
Evaluate affected processes, documents, customers, suppliers, and parts before implementing a change.
Cost Tracking
Capture cost estimates, actuals, and supporting files for better planning and reporting.
Audit Trail and Compliance Controls
Maintain traceability and readiness for ISO audits and FDA inspections.
Stakeholder Notifications
Notify teams automatically when changes are approved and completed.

Connected Platform
Trackmedium's eQMS Management of Change module is part of our eQMS platform and fully integrated with other quality modules. It enables seamless connectivity, streamlined workflows, and complete traceability across all quality processes.
Management of Change Lifecycle at a Glance
Trackmedium's eQMS Management of Change module supports the complete lifecycle:
Initiate Change, Define the current state, proposed change, and reason. Add supporting details and attachments.
Initial Approval, Route the record for evaluation by an assigned reviewer.
Develop, Implementation Plan Add action items with assignees and due dates.
Approve Plan, Final approval before execution, ensuring alignment and readiness.
Execute Implementation, Assigned users carry out tasks. Progress, cost, and delays are tracked.
Verify and Close, Confirm that the change was implemented effectively and close the record. Stakeholders are automatically notified.
Built for Quality-Driven Industries
Trackmedium's eQMS Management of Change module is trusted by organizations across both regulated and non-regulated sectors. Whether you need to comply with strict standards or simply want to drive operational excellence, Trackmedium eQMS adapts to your quality goals.
Regulated Industries
Ideal for organizations that must comply with global regulations and standards such as ISO, FDA, and 21 CFR Part 11.
Non-Regulated & Growth-Focused Sectors
Perfect for companies seeking to strengthen quality culture, reduce operational risk, and improve efficiency - even without formal compliance mandates.
Why Trackmedium eQMS?
Minimize Risk
Identify, assess, and address risks before implementing the change.
Maximize Accountability
Assign responsibilities and track every action in real time.
Gain Visibility
Use dashboards to monitor change status, delays, and cost impact.
Frequently Asked Questions
Can we use this for both product and document changes?
Yes. You can manage changes to documents, suppliers, equipment, processes, and more.
Is the workflow configurable?
Yes. You can define your own steps, routing rules, reviewers, and field requirements.
Can we assign multiple tasks to different users?
Yes. The Action Plan lets you assign individual tasks to multiple users with separate due dates and review steps.
Can we track costs related to the change?
Yes. Use the Cost tab to enter estimates, actual costs, and related files.
Can we attach documents and link records?
Yes. You can attach files and link related documents, Corrective Actions, suppliers, and other records.
How do we verify that changes were effective?
A verifier completes a dedicated step after implementation to confirm success.
What happens if an action item is delayed?
The system adjusts the overall deadline and notifies the assignee and change owner.
Will users be notified automatically?
Yes. Notifications are sent at each key step based on your configuration.
Can we create change records from other modules?
Yes. You can initiate changes from Document Control, Corrective Action, and Supplier Management.
Is there a full audit trail?
Every status change, field update, and routing action is logged.
Is the module mobile friendly?
Yes. You can manage and review changes from your tablet or smartphone.
Does it support ISO and FDA compliance?
Yes. The module supports ISO 9001, ISO 13485, FDA 21 CFR Part 820, and other relevant standards.
See more questions
Ready to Take Control of Change?
Implement a consistent, traceable, and scalable approach to change management with Trackmedium eQMS.
Implement a consistent, traceable, and scalable approach to change management with Trackmedium eQMS.
