For GDP: How do you work with electronic, hard-coded footnotes on a form and when you start handwriting on the form, you need to footnote something? Would you start with the next available number from the electronic version or would you keep them separate and start at 1 for handwritten ones? We are ISO 13485 certified.
Electronic and hand-written footnotes for GDP
- Thread starter rlangeZMC
- Start date
I can honestly say that I've never encountered this! 
Makes me wonder about the complexity of the form. To be sure I understand, the form template is maintained electronically and contains numbered footnotes. When you execute the form (create a record), you print and sometimes need to apply handwritten footnotes?
It's really all about data integrity. You should just ensure you're complying with the ALCOA principles. Are the (handwritten) footnotes Attributable, Legible, Contemporary, Original, and Accurate. To keep them identifiable, maybe label them as H1, H2, etc. (Handwritten 1)? To complete the thought, to help ensure they are attributable, it's pretty standard practice for the author to sign / initial the (handwritten) entry and date it.
Makes me wonder about the complexity of the form. To be sure I understand, the form template is maintained electronically and contains numbered footnotes. When you execute the form (create a record), you print and sometimes need to apply handwritten footnotes?It's really all about data integrity. You should just ensure you're complying with the ALCOA principles. Are the (handwritten) footnotes Attributable, Legible, Contemporary, Original, and Accurate. To keep them identifiable, maybe label them as H1, H2, etc. (Handwritten 1)? To complete the thought, to help ensure they are attributable, it's pretty standard practice for the author to sign / initial the (handwritten) entry and date it.
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