S
snoopy2017
Hi everyone,
Can somebody explain to me the difference between a change control form and a document change notification?
I worked at a fairly large medical device company where change requests were completed using a "document change notification (DCN)" form. The sign-offs by the required approvers are at the end of the form. There is only one section for signatures.
In my new role at a smaller company, I noticed that the form is called "Change Control Form" where the change requester (somebody who initiates a new document or plans to revise a document) first gets approval from their department, and at the discretion of RAQA, the change request is approved or pushed to a Change Control Board (CCB) for further assessment. I am not fully understanding the purpose of sending a request for further assessment by a CCB when the department has given the go-ahead to change the document. The final revised document is then circulated to a designated group of SMEs for review. Can the CCB step be skipped? As it is, the form requires signatures at multiple sections.
Perhaps a smaller company works in a different way from a larger company. If anyone has a sample change control or document change notification form, could you please share with me?
Please let me know if you have advice.
Can somebody explain to me the difference between a change control form and a document change notification?
I worked at a fairly large medical device company where change requests were completed using a "document change notification (DCN)" form. The sign-offs by the required approvers are at the end of the form. There is only one section for signatures.
In my new role at a smaller company, I noticed that the form is called "Change Control Form" where the change requester (somebody who initiates a new document or plans to revise a document) first gets approval from their department, and at the discretion of RAQA, the change request is approved or pushed to a Change Control Board (CCB) for further assessment. I am not fully understanding the purpose of sending a request for further assessment by a CCB when the department has given the go-ahead to change the document. The final revised document is then circulated to a designated group of SMEs for review. Can the CCB step be skipped? As it is, the form requires signatures at multiple sections.
Perhaps a smaller company works in a different way from a larger company. If anyone has a sample change control or document change notification form, could you please share with me?
Please let me know if you have advice.