Regulatory Compliance Management

ENOVIA is the collaborative innovation application which powers Dassault Systèmes suite of innovation solutions. ENOVIA solutions cover a large range of business processes—from project and program management to system engineering, product development and regulatory compliance—while providing dedicated tools for IT professionals implementing V6.

Managing Compliance with Regulations

Compliance with government and industry regulations is critical to the successful launch of new products. Failure to do so can result in missed market opportunities, product recalls and even, in some cases, large fines that will impact a company’s bottom line. ENOVIA helps companies to be compliant in three main areas: material compliance, intellectual property access and exchange and product quality.

Material Compliance

Meeting environmental compliance throughout the product development process is a must for companies that operate globally. This is especially true for High-Tech and Automotive manufacturers who must meet the European Union’s (EU) Restriction of the use of certain Hazardous Substances (RoHS), Waste Electrical and Electronic Equipment (WEEE), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Packaging, and/or End-of-Life Vehicle (ELV) regulatory directives, along with similar directives emerging in Asia and North America. With Dassault Systèmes’ Regulatory Compliance Management solution, companies can verify and integrate compliance regulations at every phase of the development process. Product companies can avoid late-stage design changes and explore ways of improving product designs while still meeting compliance requirements. Companies can also reduce or eliminate the use of hazardous materials and substances in their products, avoiding problems such as launch delays, recalls, fines, poor customer satisfaction and a damaged public image.

IP Access and Exchange

Successful operation of a multi-party PLM system includes proper protection of the intellectual property (IP) of the parties involved. The IP may belong to a commercial organization or its disclosure may be restricted by government. In all cases, there is a need to prevent exposure of information to unauthorized individuals or information transfer to unauthorized locations. ENOVIA's Regulatory Compliance Management solution allows organizations to properly protect intellectual property, whether that is their own IP, or that of others, from unauthorized access. Dassault Systèmes’ PLM system safely manages all relevant product data in the enterprise while allowing the sharing of information based on user credentials that can include citizenship, country-of-birth, organization affiliation or location.

 

Product Quality

Having an efficient process to capture, track, investigate, and take action on field complaints, product inquiries and equipment service requests is critical to improve product quality and, in some industries, is mandatory to launch and sell products in the market. ENOVIA's Regulatory Compliance Management solution enables organizations to respond quicker to market opportunities by streamlining product design to help prevent problem recurrence in future processes and designs. It provides an holistic solution by integrating with other related product lifecycle processes to effectively remove the source of the problems. Dassault Systèmes PLM enables organizations to bring industry-leading products to market quicker, with more reliability and realtime visibility into downstream problems, by linking product design data directly to customer complaints and non-conformances.

Regulatory Compliance Solution includes:

  • Materials Compliance Analysis
  • Supplier Material Declarations Management
  • IP Classification Management
  • IP Export Control Management
  • Product Complaints Capture and Investigation
  • Non Conformance Reports (NCRs) Management
  • Equipment Services Requests (ESR) Management
  • Corrective and Preventive Actions (CAPA) Management
  • Quality Audit Management

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Zusätzlich zu PLM (Product Lifecycle Management) bietet Dassault Systèmes, die "3DEXPERIENCE Company", geschäftlichen und privaten Nutzern eine virtuelle Welt, in der ihren Ideen zur nachhaltigen Innovation keine Grenzen gesetzt sind. 3DSWYM, 3D VIA, CATIA, DELMIA, ENOVIA, EXALEAD, GEOVIA, NETVIBES, SIMULIA und SOLIDWORKS sind Handelsmarken oder eingetragene Handelsmarken von Dassault Systèmes oder seiner Tochtergesellschaften in den USA und/oder anderen Ländern.