It enhances compliance, collaboration, and efficiency in handling critical safety documents and processes.

Key Features

• Centralized Content Management:
  • Pharmacovigilance System Master Files (PSMFs): Centrally manages global and local PSMF documents, ensuring they are up-to-date and easily accessible.
  • Pharmacovigilance Agreements (PVAs): Tracks PVAs and partner data obligations, facilitating compliance and oversight.
  • Periodic Reports: Streamlines the assembly and authoring of periodic safety reports, ensuring timely and accurate submissions.
• Safety Signal Management:
  • Literature Articles: Stores and manages literature articles relevant to safety signals and pharmacovigilance activities.
  • Safety Signal Investigations: Supports the investigation and documentation of potential safety signals, enhancing the ability to respond to emerging safety concerns.
• Operational Efficiency:
  • Automated Processes: Automates the creation, review, and approval workflows for safety documents, reducing manual effort and increasing accuracy.
  • Real-Time Collaboration: Enables global collaboration across teams and external partners, improving communication and decision-making.
• Compliance and Reporting:
  • Regulatory Compliance: Ensures all safety content management processes comply with global regulatory requirements.
  • Audit Trails: Maintains detailed audit trails for all document activities, ensuring transparency and accountability.
• User-Friendly Interface:
  • Intuitive Design: Features an easy-to-use interface that simplifies the management of complex safety documents.
  • Training and Support: Provides comprehensive training and support resources to help users maximize the platform’s capabilities.

Benefits

• Enhanced Compliance: Ensures that all safety-related documents and processes meet regulatory standards, reducing the risk of non-compliance.
• Improved Efficiency: Automates and streamlines safety content management, reducing administrative burden and speeding up document processing times.
• Better Collaboration: Facilitates better communication and collaboration between internal teams and external partners, leading to more effective safety management.
• Increased Transparency: Provides real-time visibility into the status of safety documents and processes, improving oversight and decision-making.