What auditors actually look for in software documentation (and what modern audits look like after QMSR)

Most SaMD teams build documentation to satisfy their QMS. Auditors review it looking for something different: evidence that the team actually understood what they were building, managed the risks in front of them, and can trace decisions from requirements through to verified output.

In this session from the Greenlight Guru Software Enabled Devices Virtual Summit, Andrew Cole of Cannon Quality Group breaks down what FDA investigators and notified body auditors are actually looking for in software documentation after QMSR, and how modern audit practice has shifted from checklist review to systems thinking.

Watch now!