Regulatory Document Authoring & Management

Corporations have recognized the need to proactively manage constraints imposed by regulatory bodies and or best practices in Product Compliance. This market overlaps other emerging areas impacting the value chain product lifecycle management, and Governance Risk and Compliance.

More importantly, Product Compliance is an extension of Enterprise Resource Planning (ERP) and Supply Chain Management (SCM). Through integration with these systems, and by providing enhanced optimization, planning, and execution capabilities, Product Compliance is destined to become the next link in the corporate IT “backbone.”

Strategic Approach

At the strategic level, a company must proactively plan all major long-term elements of corporate strategy. This traditionally includes financing, manufacturing and logistics capacity, product development, marketing and others. Today many organizations are struggling to integrate product compliance into the strategic plan. This integration is desirable for the following reasons:

• Long viewed by industry as strictly a cost, compliance is now being viewed by forward thinking companies as an additional set of constraints imposed on the market, no different from materials, production capacity, logistics, or other constraints in the value chain. The company that best manages these compliance constraints will secure a new competitive advantage.
• Integrating hazardous materials management as part of a holistic research and development process can optimize the business for product compliance. When compared to traditional product engineering “in isolation” and simple compliance execution after-the fact, this approach has significantly greater potential for economic value-add.

Tactical Approach

The tactical level is where intelligent decision support may be deployed to assist Regulatory Affairs and/or Product Stewardship professionals in making informed decisions. Intelligence automates the collection and application of data, and makes mundane decisions about that data. When applied at the corporate or division level, it can significantly reduce the cost of doing business and provide added economic value for the enterprise.

At the tactical level, the proper tools are needed to implement and manage consistent policies and procedures across the enterprise.

This is desirable for the following reasons:

• Organizations typically employ a “top-down” approach to Compliance policy and procedure management. Emulating this approach in the Product Compliance system ensures compliance regardless of organizational issues or the regulatory complexity of markets served. It also ensures data and workflow integrity enterprise-wide without adversely impacting day-to-day activities at the operational level.
• Beyond compliance, Regulatory Authoring and Management tools provide consistent views of the enterprise for Product Compliance and corporate managers. This leads to better analysis and understanding of Prodcut Compliance issues, resulting in process improvement and greater efficiencies.

Operational Approach

At an operational level, broad and integrated Product Compliance functionality is needed to execute day-to-day EHS activities. This is desirable for the following reasons:

• To ensure compliance, organizations need to share information across functional lines and between different locations. Integrated Product Compliance functionality creates a common data platform for sharing information. Integration also creates new synergies and streamlines business processes.
• Organizations must constantly manage tradeoffs between improved business processes and greater systems complexity. Integration reduces overall complexity and lowers total cost of ownership.
• Managing functional silos consumes human resources. Integration presents opportunities to consolidate functional silos, thus reducing costs of training, manning, and maintaining those functions.