Software Validation Templates

Templates for the software validation as a medical device that will be cloud-based. The template set should be compliant with FDA software validation, good practice (GxP), or good manufacturing practice (GMP) and the ISO IEC 62304 framework set should address the following:

Design Qualification (DQ)

Installation Qualification (IQ) for Install

Installation Qualification (IQ) for Upgrades

Operational Qualification (OQ)

Performance Qualification (PQ)