• Windchill QMS Foundation (General and Med Device)— Includes the QMS foundation data, Failure Mode, Failure Effects and Harm Hazard. QMS foundation does not include QMS module features of Windchill CAPA, Windchill Nonconformance, Windchill Customer Experience Management, or Windchill Audit. To avail QMS module features, select individual modules, QMS Surveillance and Corrective Action (General) as a group, or Windchill QMS Surveillance and Corrective Action (Med Device) as a group based on the business requirement or license features.

• Windchill QMS Surveillance and Corrective Action (General) — Includes a general version of Quality Management System in which you can create product related activities. This module supports Windchill CAPA, Nonconformance, Customer Experience Management and QMS Foundation. This module is recommended for users from the non-medical industry, such as, automobile and electronics industry. Creation of a regulatory report for a customer experience object is not supported.

• Windchill Audit Management (General) — Includes the full functionality of Audit management, such as, creating and editing audits, and generating audit summary reports in conjunction with Windchill QMS Foundation. This module supports association with Windchill CAPA and Windchill Nonconformance.

• Windchill Regulatory Master (Med Device) — Includes the full functionality of Windchill Regulatory Master, such as, creating, editing, and viewing a regulatory submission. This module enables users to make regulatory submission to the regulatory agencies and follow-up on the regulatory submission in conjunction with Windchill QMS Foundation.

• Windchill Unique Device Identification (Med Device) — Includes the full functionality of Unique Device Identification (UDI), such as, creating, editing, and viewing a UDI. This module enables users to assign a unique identifier to medical devices in all geographies.