Installing the Windchill Quality Management System
To install the Windchill Quality Management System (QMS), use the PTC Solution Installer (PSI).
You can install a single component or a combination of Windchill Quality Management System components from the following options on the PSI installer:
• Windchill QMS Foundation (General) — Installs 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 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) — Installs 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 QMS Surveillance and Corrective Action (Med Device) — Installs the full functionality of QMS. This module supports Windchill CAPA, Windchill Nonconformance, and full capability of Windchill Customer Experience Management. It incorporates predefined templates and processes to support the medical devices industry regulations.
• Windchill Audit Management (General) — Installs 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 Dev) — Installs 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 Dev) — Installs 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.
Depending on the components selected on the PSI for installation, a combination of quality solutions may get automatically selected or greyed out.
Additional points to consider when installing or upgrading Windchill Quality Management System:
• When selecting products to install, select Windchill PDMLink and Windchill ProjectLink in addition to the quality solutions such as Windchill CAPA, Windchill Nonconformance, or Windchill Customer Experience Management.
• When selecting data sets to load, select Create database schema and Load base data. For a production installation, do not select Load demo data.
• If Windchill CAPA is already installed, you can install Windchill QMS Surveillance and Corrective Action (General) or Windchill QMS Surveillance and Corrective Action (Med Device). Installation of Windchill QMS Surveillance and Corrective Action (General) and Windchill QMS Surveillance and Corrective Action (Med Device) are mutually exclusive. Installation of Windchill QMS Foundation is not supported because this module is automatically installed with Windchill CAPA.
• In case of upgrade, if you have installed Windchill Customer Experience Management with full capability, you will be required to upgrade to Windchill QMS Surveillance and Corrective Action (Med Device).
For more information, see the following topics:
General Notes
• If you have installed QMS Surveillance and Corrective Action (General) modules then in Preference Management, Regulatory Reports related preference will be displayed in Quality group of preferences.
• If you have installed only QMS Foundation (except any other QMS modules) with any other windchill modules like PDMLink, then Lessons Learned classification tree will be loaded on the server. As the Customer Experience Management module is not installed on the server, the Lessons Learned classification tree will be of no use in the system.
• If you have installed QMS Surveillance and Corrective Action (General) modules then Med Device related Classifications trees will also be displayed in Quality Classification Tree Administration.