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Is it acceptable per 21CFR820 to have a dynamic controlled form?
The form is controlled document that contains interactive fields that can be completed. The form format and content cannot be altered. The information or data is completed the form is then printed and signed. Is this acceptable documentation practice to be able to enter data electronically into a controlled form and become part of the device history record?
For example a CAPA form where information regarding the CAPA can be electronically typed, printed then signed.
Thank you.
The form is controlled document that contains interactive fields that can be completed. The form format and content cannot be altered. The information or data is completed the form is then printed and signed. Is this acceptable documentation practice to be able to enter data electronically into a controlled form and become part of the device history record?
For example a CAPA form where information regarding the CAPA can be electronically typed, printed then signed.
Thank you.