Data Integrity Audit Report for Production Software as a Medical Device

This sheet provides guidance for completing a data integrity audit aligning with several different requirements, including FDA 21 CFR Part 11, EU GMP Annex 11, and several other regulations.

How to use these templates:

• Click on the links to access the templates

  • If you are a Google Workplace organization, make a copy by going to File > Make a copy

  • If you are not a Google Workplace organization, download a copy by going to File > Download and selecting your preferred file type (available as DOCX, PDF, and more)

• Review and then remove instructional text

• Save in a centralized place

• Attach to evidence either through Integrations, Automated Collection, or direct upload