VALIDATION IS REQUIRED BY FDA 21 CFR PARTS 11 & 820
All pharmaceutical and medical devices, most dietary supplements, and some F&B companies are required to validate their Quality Management Software (QMS) solutions regularly.
Continuous validation of applications can be extremely time-consuming when performed manually.
How Does Continuous Validation Work?
XLM SIMPLIFIES AND AUTOMATES THE VALIDATION PROCESS BY PROVIDING:
Continuous Validation for Intellect apps
Automated testing in a dedicated test instance
Deliverables include:
Validation Plan (VP)
Configuration Qualification (CQ) Protocol
User Acceptance Test (UAT) Protocol
Trace Matrix
Validation Summary Report (VSR)
Customers to provide User Requirements Specifications (URS)