ExtraView Adverse Event reporting is a web-based solution that features unprecedented flexibility and ease of use. Used by the world's largest medical device and pharmaceutical companies, ExtraView is the foundation for global capture, analysis, and resolution of adverse events related to medical device, treatment and diagnostic systems. ExtraView can easily manage electronic submissions and automate the generation of regulatory forms such as MedWatch and CIOMS. Reporting and analysis of each case history is built-in, with a complete and automatic audit trail for follow up.

Key Features

• Web-based - Standard web browser access with no client software to install. Unlimited number of role-based layouts, views, queries and options
• Configuration - Multiple forms or departmental business areas within a single database. Add an unlimited number of custom fields and an unlimited number of user roles
• Workflow Management - Workflow may be defined for each role, form and project. Rule workflow administration allows for validation of data and processes
• Reporting – Create and save public or personal reports. Report types include: Column reports, Summary reports, Matrix reports, Dashboard reports, Aging reports, Container reports, Planning reports and Custom reports. Reports may also be output to the browser, to Microsoft Word, to Microsoft Excel, Adobe PDF, or text formats
• Electronic Signatures - Configure electronic signatures on any criteria, to provide reauthentication at the time of update, conforming with regulations such as 21 CFR Part 11 and 21 CFR Part 820
• Audit Trails – Changes to any field on a form are part of a full, visible audit trail. Each change is time stamped and annotated with the name of the person. All changes to the underlying system metadata as well as all user access are also recorded in an audit trail
• Notifications - Automatic and rule based notifications. Alerts and updates can be sent and received through email. Reports can be scheduled and sent by email on a periodic basis
• Security - All fields are controlled with field-level security permissions for each role: read/write access, read-only access, no access. All key data collection functions are protected by a role-based security key. Definable password policies and expiration procedures. Electronic signatures may be defined for any step in the workflow. There is extensive control over all the application to prevent unauthorized usage.

A few of the benefits of using ExtraView

• All inclusive system with controlled user access and audit trails
• Track communication with health authorities
• Change control with all regulatory submissions
• Track and manage all phases of the regulatory process, product life cycle and submission process
• Report registration status by country, product , label, dosage or any other classification
• Integrate with other document management, Clinical Trial Document (CTD), SOP tracking and regulatory auditing systems
• Regulatory notifications or approvals as a result of change controls Manage and track regulatory
• Reporting processes including product safety update reports (PSURs), with links to original submissions
• Quicker response time to resolving warning letters or other issues
• Provide real-time alerts and notifications to relevant health authority correspondence