Concerning the responsible person for a document update task: What happens if the original author of a document update task is no longer with the company?
In such scenarios, it's advisable to have a predefined process ensuring the seamless transfer of responsibilities to a designated replacement. This ensures continuity in document management. When the document initiates a new approval or review cycle, the designated replacement will receive notifications and can take over the task.
Additionally, utilizing the feature allowing the addition of a due date ensures that all relevant users are notified. Thus, even if the author role becomes vacant due to user deletion, the designated replacement can step in and fulfill the required responsibilities promptly.
If there are multiple Update document tasks for the same document from different Change Requests, and only part of the requested changes are implemented, can the not-yet-implemented Update document tasks be left open for future updates?
Unfortunately, the system automatically marks the Update Document task as closed once the document completes a full approval cycle. Consequently, if the same document is included in multiple Change Requests simultaneously, and only some changes are implemented resulting in a new document version, all Update Document tasks related to that document in all Change Requests will be closed.
If a task involves updating a document that is already in draft, review, or (QA) approval status, what happens? Will the parties involved be notified of the impact on their ongoing document?
If the documents included in the task are not in Approved not Published or Published status at the task's creation, the task won't be completed until these documents finalize their ongoing approval cycle and undergo another full cycle. This means the documents must complete a full approval cycle before the task is finalized. Authors will receive email notifications when the Change Request reaches Implementing status, alerting them that the document(s) need updating.
If the change request document is set to "denied" instead of rejecting to draft, is that the end of the change request? Can it no longer be edited?
When a Change Request is marked as "Denied," only Approvers have the authority to revert it to the "Under Signing By Approver" status. However, providing a Remark/Reason is mandatory to reverse the Change Request back to its previous status.
Can you upload a file after closing the task?
You can upload it into the files tab, but you won't be able to upload it into the task that was already closed. You can upload it to the files tab, and simply mention that it was related to a specific task.
About SOPs linked to a CR and/or a CAPA. Is possible to eliminate a SOP (under review phase) if it is linked to a CR or a CAPA?
It is not possible to delete a document if it is added as an Update Document Task in a Change Request. You will first need to remove the task in the CR and then delete the document.
How can change requests be modified during the change process in Scilife, especially when big changes arise?
Adapting Scilife to fit your specific process is key. For instance, let's consider scenarios like medium and major releases. Initially, a change request is created with a comprehensive description of the expected changes in the new version. All related tasks are linked, and after obtaining approvals, the request progresses to implementing status.
However, unforeseen circumstances may prompt the need to incorporate new features or tasks. Once a change request reaches implementing status and has been approved by the approver and by QA, direct editing of the description becomes restricted. To address this, our approach involves documenting changes in the comments tab. This includes adding additional tasks or mentioning new features to be included. This method ensures transparency and traceability.
But it depends on your process. Some customers opt to close tasks and create new ones if changes are substantial. They annotate closure remarks, explaining why tasks were not carried out and indicating the creation of a new change request. Others choose to close the entire change request and its associated tasks, initiating a new change request process.
Moreover, some utilize the option to reopen the change request. After closing all tasks and obtaining QA sign-off, the request is reopened and reverted back to draft status. This allows for the reopening and editing of tasks as needed.
