Life Sciences AER

Life Sciences AER by ExtraView offers a comprehensive web-based solution for adverse event reporting in medical device and pharmaceutical industries. Widely adopted by major global companies, it facilitates the capturing, analysis, and resolution of adverse events associated with medical devices, treatments, and diagnostics.

One of the key features is its unprecedented flexibility and ease of use, allowing electronic submissions and automated generation of regulatory forms such as MedWatch and CIOMS. It integrates built-in reporting and analysis of case histories, maintaining a comprehensive and automatic audit trail for follow-ups.

Key Features

• Web-based Access: Access through standard web browsers without needing client software installation.
• Unlimited Customization: Create an unlimited number of role-based layouts, views, and queries. Customize fields and user roles as needed.
• Workflow Management: Define workflows for roles, forms, and projects with data and process validation.
• Comprehensive Reporting: Create and save a variety of report types, including column, summary, matrix, and dashboard reports. Outputs can be to browsers, Word, Excel, PDF, or text.
• Electronic Signatures: Configure to ensure reauthentication, complying with regulations like 21 CFR Part 11.
• Audit Trails: All form changes are timestamped and annotated with user details. System and user access changes are also recorded.
• Automated Notifications: Rule-based notifications with email alerts and periodic report scheduling.
• Security: Role-based security with field-level control and password policies to prevent unauthorized access.

Moreover, the system offers controlled user access and detailed audit trails, tracks communication with health authorities, manages change control, and oversees all phases of the regulatory process. It provides real-time alerts and notifications, integrating seamlessly with document management and clinical trial systems to ensure efficient and compliant operations.