Compliance Management

Teamcenter’s enterprise knowledge and process management empowers employees to support compliance in their daily tasks. Teamcenter supports compliance management in a general sense by 1) capturing regulatory requirements early in the product lifecycle and integrating those requirements into the product definition as it evolves; 2) providing the process visibility and integrity to empower employees to respond to regulatory issues; and 3) providing access to the right product information at the right time.

Teamcenter for Compliance Management solutions offer the following benefits:

• Facilitate design-for-compliance initiatives
• Provide product developers with rapid visibility to all compliant and non-compliant components
• Integrate compliance management capabilities into current business processes
• Minimize risk of non-compliance
• Reduce total cost of ownership
• Minimize cost associated with excess and obsolete inventory otherwise caused by the use of non-compliant parts

With its robust knowledge management framework for configuration management, record keeping and audit tracking, Teamcenter supports compliance mandates including financial and product records management and archiving, and document and records retention management. Beyond capabilities to support compliance in a general sense, Teamcenter also offers specific solutions for compliance:

• Environmental Compliance
• Medical Compliance
• Export Control
• Document and Records Management

Environmental Compliance

To address overall compliance objectives while enabling product makers to specifically comply with the End-of-Life Vehicle (ELV), Restriction on the Use of Hazardous Substance (RoHS) and Waste from Electrical and Electronic Equipment (WEEE) directives, UGS offers Teamcenter’s Environmental Compliance solution for the end-to-end collection, management and reporting of environmental compliance and material content information.

Teamcenter’s Environmental Compliance solution enables product developers to easily capture detailed material and substance data that pertains to each of the components provided by the product’s various suppliers. This data is captured in the form of product requirements. Once the material and substance data is captured by Teamcenter, product developers can relate this data to a hierarchical model that fully defines a part in terms of its underlying substances, material composition, technical materials, part composition and environmental part data.

Medical Compliance

To specifically comply with requirements for the medical devices industry, UGS offers Teamcenter’s Medical Compliance solution. The Teamcenter solution allows customers to manage digital product information across the lifecycle in accordance with regulatory requirements such as those established by the U.S. Food and Drug Administration (FDA). Teamcenter provides improved reliability and enhanced product quality at reduced costs, while at the same time fulfilling FDA requirements for new product introduction.

Within FDA requirements, the Good Manufacturing Practice (GMP) - 21 CFR Part 820 calls for process and organization control to ensure authenticity, integrity and confidentiality on all product records from design, manufacture, testing, packing, storage, installation and service to retirement of medical devices. 21 CFR Part 11 provides rules for acceptance of electronic records and signatures.

Teamcenter’s Medical Compliance solution provides a reliable quality assurance environment as per FDA requirement of 21 CFR Part 11 and Part 820, to create, manage, control, track and distribute all electronic product records associated with the lifecycle of a product.

Export Control

In this digital age, Governments around the world are concerned about controlling the export of information. For example, the U.S. International Traffic in Arms Regulations (ITAR) governs the sharing of technical information between U.S. companies and foreign nationals, regardless of where that access occurs (whether in the U.S. or abroad). These regulations hold companies accountable for the acts of anyone in their employ who shares technical data. Penalties for export violations can be severe -- $1M and 10 years in prison per violation, prohibitions against future exports by the company, and the loss of government contracts.

Teamcenter’s Authorized Data Access solution integrates export control-specific security measures at the program level within Teamcenter’s knowledge management and collaboration environment. Teamcenter provides secure, web accessible access to export-controlled documents and data, with extended search and navigation capabilities. Access is limited to entitled employees, partners, suppliers and customers – classified by security ranking and country – essentially limiting their ability to violate export controls. In addition to preventing violations, Teamcenter also enables processes and audits to ensure the identification and investigation of any potential infractions.

Document and Records Management

The standardization of document and records management policies and procedures ensures that appropriate protection is given to all records and that the evidence and information they contain can be retrieved more efficiently and effectively, using standards and procedures. Document and records management is a challenge for both commercial and government sectors, worldwide.

Within the U.S., there are specific standards that have been established for document and records management. For example, the U.S. Department of Defense’s 5015.2 standard provides implementing and procedural guidance for the management of records in the DoD. This standard establishes mandatory baseline functionality requirements for Records Management Application (RMA) software used within the DoD and on government projects.

The Sarbanes-Oxley Act of 2002 provides a second example with the most significant act of the U.S. Congress to bring changes to corporate governance, putting compliance issues at the forefront for U.S. public companies. The Sarbanes-Oxley Act presents significant implications for how U.S. public companies document their business processes and internal controls. Similar legislation is being enacted by other governments around the world.

Teamcenter’s document and records management capabilities help meet the DoD 5015.2 and Sarbanes-Oxley (SOX) requirements, along with other mandates, with document management and workflow capabilities that enable compliance. Teamcenter provides a centralized and organized way to maintain documentation and to access information securely with appropriate rights from anywhere using the internet, including resources external to company. It enables documents to be routed via workflows and tracks action plans with due dates, responsible personnel, reviewers, etc. Most importantly, Teamcenter archives and rolls forward information to support subsequent years’ efforts.