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Aaria
Does anyone have a procedure for the labeling review/approval and specifications matrix?
Procedure for Labeling Review and Approval and Specifications Matrix
I'm not sure what kind of matrix you are describing.
With regards to labels, there are probably 2 different things you'll want to specify:
1. Approvals of labels outputs (e.g. templates, print-files) during design & development
2. Review/check of labels during assembly or quality release
Personally, I wouldn't complicate this. For us, approval of label design outputs is by representatives from Quality, Regulatory, the Project Manager, and (depending on the label) Marketing.
Review/checks of physical labels put on devices are done by anyone trained on quality release processes.
Of course, this probably scales depending on the nature of the company and the product. ...but for us, this is a pretty simple general system. No need for a matrix.
Hope this helps.
With regards to labels, there are probably 2 different things you'll want to specify:
1. Approvals of labels outputs (e.g. templates, print-files) during design & development
2. Review/check of labels during assembly or quality release
Personally, I wouldn't complicate this. For us, approval of label design outputs is by representatives from Quality, Regulatory, the Project Manager, and (depending on the label) Marketing.
Review/checks of physical labels put on devices are done by anyone trained on quality release processes.
Of course, this probably scales depending on the nature of the company and the product. ...but for us, this is a pretty simple general system. No need for a matrix.
Hope this helps.
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