PLM Validation Application

Gateway's PLM Validation application provides a framework for creating the documented evidence required by medical device manufacturers to comply with both the technical and procedural aspects of the US Food and Drug Administration (FDA) 21 CFR Part 11 and 21 CFR Part 820.

Validation is necessary to ensure a PLM system is working properly, and provides correct information to assist an organization in designing and manufacturing products that are safe and effective. Validation is also required for PLM software that is used in the quality system, including any customizations created internally or by outside consultants.

Gateway Group's PLM Validation Application reports:

  • Risk Management
  • Requirements Management
  • Test Protocols
  • Test Results
  • Test Status Reporting
  • Issue Resolution

Consulting Overview
Methodology
Initial Study
Business Case
IT Strategy
System Requirements
Vendor Selection
System Design
Project Management
Validation