Increasing regulation is a trend in the life sciences, automotive, and high-technology industries that can slow time to market or, when compliance is not achieved, derail the product lifecycle altogether. Companies and products must comply with a multitude of standards, regulations, and due diligence requirements, including:
- Corporate standards, such as those set by the International Organization for Standardization (ISO 9000, 14000, 13485)
- Environmental and safety regulations, such as those set by the U.S. Food and Drug Administration (FDA)
- Industry-specific regulations, such as those set by the U.S. Securities and Exchange Commission (SEC) or the U.S. Department of Defense (DoD)
Periodic audits by these regulatory bodies and customers mean product lifecycle processes must be transparent and audit ready.
Download the Oracle® Agile Governance & Compliance (PG&C) Datasheet
Inspirage is a leading implementer of Agile Product Governance and Compliance enables organizations to manage the compliance of their products against government and industry standards and regulations. By integrating the product record with these requirements, Agile PG&C allows companies to manage product policies and operations within a system that has built-in compliance support. When users and managers conduct internal and external audits, management reviews, and closed-loop continuous improvement processes, the system prompts them to validate or correct critical governance and compliance processes. Proper procedures can be communicated automatically to the appropriate personnel to maintain continuous compliance and address failure points. The solution merges compliance activities with the enterprise product record, allowing companies to more-reliably comply with environmental standards, create policy documentation, and design green or compliant products from the start, thereby reducing the risk of costly business interruption or shutdown.
Key Agile Product Governance & Compliance Features:
- Environmental compliance functionality
- ROHS, WEEE, etc.
- Automated compliance validation
- Due diligence support
- DOD, ISO guidelines, Conflict Minerals, etc.
- Hazardous materials risk analysis
- Material declarations and certificates of compliance
- Industry and third-party compliance data
- Full Material Disclosure Support
- Substance & Bill of Substance, Compositions
- Compliance linked to the product record
- Track and maintain full compliance
- Prevent costly delays and product recalls
- Increase data transparency
- Reduce business interruption risk
- Decrease product and operations costs
- Incorporate compliance into product design
From an Agile PLM Compliance perspective, Inspirage has market-leading experiences and expertise in driving automation, integrations and user acceptance, including, but not limited to:
- REACH: (Prior to 9.3.2, this required extensions to standard product)
- IPC (1752-x), IHS and TPP Integrations, as well as other integrations from compliance/content sources
- Bill of Substance creation/management
- Conflict Minerals enablement
- Custom Exports and Reports