It provides a unified platform to manage quality events, document control, and compliance, ensuring efficient and compliant operations.

Key Features

• Comprehensive Quality Management:
  • Deviations and CAPAs: Manages deviations, corrective and preventive actions (CAPAs), and other quality events with built-in best practices.
  • Change Control: Facilitates the management of change control processes, ensuring all changes are documented, reviewed, and approved.
  • Audit Management: Supports internal and external audits, including planning, execution, and follow-up on findings.
• Document Control:
  • Centralized Repository: Provides a single source of truth for all quality documents, ensuring easy access and version control.
  • Automated Workflows: Automates document review, approval, and distribution processes, reducing manual effort and increasing efficiency.
  • Compliance: Ensures documents meet regulatory requirements with electronic signatures and audit trails.
• Risk Management:
  • Quality Risk Management (QRM): Implements risk management processes to identify, assess, and mitigate risks across the organization.
  • Risk Assessments: Conducts periodic risk assessments and generates heat maps for better visibility and decision-making.
• Integration and Connectivity:
  • Vault Connections: Seamlessly integrates with other Veeva Vault applications, such as Vault RIM and Vault Clinical, to streamline cross-functional processes.
  • Supplier Collaboration: Provides access to external partners for collaboration on audit findings and supplier corrective actions.
• Real-Time Visibility:
  • Dashboards and Reports: Offers real-time dashboards and reports to track quality metrics, operational progress, and compliance status.
  • Audit Trails: Maintains detailed audit trails for all quality processes, ensuring transparency and accountability.
• Efficiency and Automation:
  • Automated Processes: Enhances efficiency with automated workflows for quality events, document control, and change management.
  • Cycle Time Reduction: Reduces cycle times for quality processes, improving overall operational efficiency.

Benefits

• Improved Compliance: Ensures all quality processes and documents meet regulatory standards, reducing the risk of non-compliance.
• Enhanced Efficiency: Automates and streamlines quality management processes, reducing administrative burden and speeding up operations.
• Better Collaboration: Facilitates collaboration between internal teams and external partners, improving communication and decision-making.
• Increased Visibility: Provides comprehensive insights into quality processes, enabling proactive management and continuous improvement.