My original record is paper approved by wet signatures on the paper.
2. The paper is then scanned and stored in PDF format.
3. The PDF file is then placed into a computer system for users to access (print out).
4. Users can view or print out the scanned PDF and use it in GxP activities.
I know I will have to validate the system but does Part 11 apply?
2. The paper is then scanned and stored in PDF format.
3. The PDF file is then placed into a computer system for users to access (print out).
4. Users can view or print out the scanned PDF and use it in GxP activities.
I know I will have to validate the system but does Part 11 apply?