Many organizations are working on initiatives to establish ownership for regulatory affairs data.

Building a Business Case • Include all steps from initiation to operation
• Address business benefits, not just IT benefits
• Align with regulatory affairs strategy
Data Quality & Management • Maintain a constant focus and plan
• Work closely with governance and data ownership
• Know your data model
Governance & Data Exchange • Increase data exchange with external parties and other business units within the company
• Understand the impact that changes to the system may have on key regulatory processes
Organizational Changes • Establish a single point of contact between business users and application support
• Empower IT and business teams to work together
Continuous Business Improvement • Focus on continuous improvement throughout the organization, not just on keeping the system validated
• Collaborate with your technology partners to maximize value