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* All init qms templates to be effective Signed-off-by: Anna Khismatullina <[email protected]> * Fix tracex files Signed-off-by: Anna Khismatullina <[email protected]> * Remove readme Signed-off-by: Anna Khismatullina <[email protected]> * Disable RBAC for tracex sandboxes Signed-off-by: Anna Khismatullina <[email protected]> --------- Signed-off-by: Anna Khismatullina <[email protected]>
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class, title, template, author, owner, abstract, reviewers, approvers, changeControl
| class | title | template | author | owner | abstract | reviewers | approvers | changeControl | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| documents:class:ControlledDocument | Change Management Procedure | ../[ONBTEMP-1] Procedure Template.md | New User | New User | This is a dummy procedure for the sandbox workspace, allowing you to play around and easily explore TraceX’s capabilities. |
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[Keep in mind that this document content is just an illustration to show you how this could look like, but please create your own content. If needed, we can put you in touch with experts to help you out.]
Scope
This Standard Operating Procedure (SOP) applies to all departments involved in initiating, reviewing, approving, and implementing changes to controlled documents, quality records, and product specifications.
The procedure is intended to ensure compliance with ISO 13485 and maintain full traceability and impact assessment of all changes.
Glossary
| Term | Definition |
|---|---|
| Change Request | A formal proposal to modify a document or process |
| Impact Analysis | Evaluation of the potential effects of a change |
Responsibilities
| Role | Responsibility |
|---|---|
| Change Owner | Initiates and documents the change request |
| QA Manager | Assesses impact and ensures compliance |
| Department Lead | Reviews feasibility and approves implementation |
Process Flowchart
The following flowchart illustrates the change control process:
Procedure
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Initiation
The Change Owner fills out a Change Request Form with a clear description of the proposed change, reason, and affected items. -
Impact Assessment
QA reviews the request for regulatory or quality impact. Relevant department leads assess technical or operational impact. -
Approval
Once assessed, the QA Manager and affected Department Leads approve or reject the request. -
Implementation
Upon approval, changes are implemented by the responsible team. Updated documents are versioned and distributed. -
Closure
QA verifies completion and closes the change request, ensuring all documentation is updated.
... [Feel free to make any changes or additions to this document during your TraceX exploration.]