Quality and Compliance

Raises Quality and Ensure Compliance

quality-complance

ENOVIA Quality Management provides an effective and efficient quality management system to enforce common quality processes, support global and local regulatory requirements and manage all quality events, such as corrective and preventive actions (CAPA), product nonconformance, and audits, across the enterprise.

In many industries, such as High Tech, Healthcare and Life Sciences, ensuring regulatory compliance is business critical. ENOVIA Compliance Management helps ensure proper product approvals and certificates in support of business sustainability as well as product safety and effectiveness.

Global operating companies must ensure materials compliance to regional environmental directives. With ENOVIA Compliance Management, compliance managers can implement a well-defined process for requesting, reviewing, and approving materials compliance. Product compliance can be assessed and documented to meet material regulations.

Key Benefits

  • Extend compliance data to a broader audience, allowing for more effective decisions and awareness
  • Integrate supplier declarations early into the product development
  • Design in material compliance and monitor in real-time
  • Establish end-to-end traceability during the development process that can be leveraged for impact analysis

Roles

Device Master Record Manager

Simplify device master record management in a single version of the truth

  • A single version of the truth—the latest product information, captured in a centralized environment.
  • Enterprise change control process between parts, specification and technical documents
  • Baseline Device Master throughout product evolution
  • Consume Device Master Record documents with a simple package and download

Materials Compliance Analysis

Allow Managers and Designers to use Materials Compliance to make better decisions

  • Allow managers to assess product compliance and supplier reporting status
  • Make outsourcing decisions based on environmental compliance or supplier responsiveness
  • Maximize use of compliant components to create eco-friendly designs
  • Track conflict mineral reporting status and rolled up smelter content

Materials Compliance Manager

Assess and report the compliance of products to material  environmental regulations

  • Calculate product compliance to industry and regional regulations from component material declarations
  • Manage the collection of of material declarations from your supplier chain
  • Determine the impact of design and outsourcing decisions on the compliance of a product
  • Perform in-depth analysis to determine root cause of compliance problems
  • Report product compliance to your customers using industry standards

Quality Checks Metrics

Visualize Quality Metrics on Product Data Structure in Dynamic Drill-down 3D Dashboards

  • Ensures companies follow and maintain models quality
  • Supports companies in checking the quality of suppliers’ models
  • Enables managers to make decisions based on facts

Quality Document Manager

Enterprise Document Control for global collaboration from creation, thru change, to distribution

  • Drive consistency with an enterprise change process across all organizations
  • Ensure relevance of the documents intended usage with Periodic review
  • Training sign-offs with Read and Understand Statements
  • Manage distribution of hard copy prints with controlled printing
  • Support for electronic signature FDA CFR 21 Part 11

Quality Manager

Integrated close-loop Quality System from non-conformance reports to corrective and preventive actions

  • Standardize the development of a closed-loop, holistic approach to CAPA activities and management
  • Manage complaint handling processes from identification and product evaluation to closure
  • Manage deviation/nonconformance identification, reporting, disposition, and resolution, with explicit documentation to ensure quality standards and compliance
  • Manage audit activities and processes from scheduling to execution to ensure quality assurance and quality systems are working as defined and approved

Regulatory Affairs Manager

Manage product market submissions, device identification registration and safety events reporting throughout the product lifecycle

  • Streamline and automate the regulatory submission planning and dossier management and approval processes
  • Manage Device Identification data and submissions
  • Manage adverse events from reportability evaluation, submission to closure

Supplier Materials Compliance Engineer

Facilitate the collection of Material Declaration from Suppliers

  • Secure environment for suppliers to view part requests and upload material declarations
  • Material declarations can be submitted in industry standard formats such as IPC 1752, JAMP, and Compliance Connect
  • Online editor provided for creating detailed material declarations for requested parts
  • Uploaded material declarations are automatically imported into Materials Compliance Manager

Bill of Materials
Management

Maintain a single version of truth

Configuration and Change Management

Ensure business agility

Design
Management

Collaborate effectively

IP Classification and Protection

Secure intellectual Property

Product Planning and
Program Management

Deliver projects on-time and under budget

Quality and
Compliance

Raise quality and ensure compliance

Strategic Customer Relationships

Exceed customer expectations

Strategic Supplier Relationships

Connect the supply chain