Regulatory Compliance

Determine product regulatory obligations, collect and assess evidence of compliance, communicate results to internal stakeholders, and report evidence of compliance to customers and regulators.

Best Practices: Key Regulatory Compliance Process Improvements Enabled by PTC Capabilities

Best Practices: Regulatory Compliance
  • Compliance requirements definition and tracking: Capture and manage multiple, evolving, material regulations (e.g., RoHS, REACH), certifications (e.g., CE Mark, FCC) and customer requirements. Determine and model applicability by region, product category and customer. Develop, codify and maintain a proactive corporate standard for restricted substances.
  • Systematic compliance evidence acquisition and validation: Collect required data and disclosures directly from suppliers and third-party data aggregators. Systematically validate, maintain and enhance data over time. Manage risk without excessive costs by targeting appropriate levels of disclosure.
  • Software development process management: Ensure software development processes are adequately defined, enforced and automated where applicable to comply with process-oriented regulatory standards.
  • Continuously monitored compliance and risk dashboards: Provide dynamic management dashboards to support compliance and risk assessment beginning early in product development and continuing throughout the product lifecycle. Integrate compliance and risk analysis results with component and supplier qualification and detail design processes and work environments.
  • Automated compliance documentation and reporting: Automatically generate accurate reports that demonstrate product compliance, support due diligence for regulatory authorities and meet customer requirements. Provide appropriate levels of disclosure for the intended audiences and systematically build a traceable audit trail.