Life Sciences Tracking Software Solutions

ExtraView Corporation has worked hand-in-hand with some of the largest companies to help them meet the special demands of life science industries. We offer solutions that reduce the cost of operations and implement regulatory compliant solutions. ExtraView solutions may be implemented as part of a validated 21 CFR Part 11 system. What's more, our solutions encourage collaboration across the enterprise and are easy to upgrade and expand as your business grows. Used by the world's largest medical device and pharmaceutical companies, ExtraView is the leading software platform to design, execute and optimize cross-functional business processes that incorporate systems, processes and people to help life science institutions overcome the many challenges they face. In a regulated environment, ExtraView enables organizations to quickly and cost-effectively, create user specific web-based solutions that conform to a corporation's unique business processes and workflow requirements.

Adverse Event Reporting

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.

Compliance Management

An ExtraView Compliance Management solution provides an integrated approach and common framework to manage requirements faced by an organization. It will follow cross-industry regulations and guidelines like FDA, OSHA, CMS, HACCP, and ISO. You can assign remedial and corrective actions as well as eliminating errors through trending and root cause analysis. Central management enables owners and auditors to focus on central issues. Real-time reporting and alert dashboards will give insight into the compliance management process. Integrate ExtraView into your existing document management system or attach any document type into ExtraView to follow change control and business processes.

Quality Management

An ExtraView Quality Management solution provides the ability to manage all issues, follow up, and provide change management in a centralized corporate solution. Point-and-click business rules and workflow ensure your SOP's are controlled at a global view and real-time data collection and reporting provides the information to make the right decisions. 21 CFR Part 11 compliant solutions allow your organization to ensure quality and have traceable audit trail by centralizing and integrating all quality processes.

CAPA & Root Cause Analysis

This ExtraView software solution enables companies to streamline their CAPA and corrective processes across the enterprise. Search for non-conformance and identify a plan of action for evaluation and closure. Capture problem data to improve operations and develop root cause analysis. Establish SOP's for both follow up and preventive plans. Real-time alerts and dashboards help ensure that your closed loop process is implemented. Report and analyze on the data collected, to track each case history and audit trail for follow up.

Clinical Trial Data

Managing clinical trial data, or even the change management process associated with large clinical trials can be managed with this ExtraView solution. In a validated environment, your process may be followed precisely, with a full audit trail and with complete security. Full notification to all interested parties of all key events ensures quick follow up. Search for anomolies and patterns in your data and use triggers to provide the automatic escalation of events out-of-specification.

Device & Equipment History

ExtraView software can help your organization keep control over equipment inventories, validation, calibration and preventive maintenance. Track and manage equipment status, work orders and equipment failures to ensure compliance. Managing multiple locations of equipment, each with their own calibration plans and work orders requires a robust system that provides effective tracking and scheduling of required maintenance tasks. Reduce your costs and lower the risk of deviations by providing a central enterprise system to manage and track all devices and equipment. You may manage equipment lifecycle from validation through retirement. ExtraView's business process rules, workflow, and alerts can send requests to appropriate stakeholders. ExtraView can also schedule and automate preventive maintenance (PM), calibration work orders, and re-validation of items. Real-time dashboards and reporting allow 24 x 7 availably for any critical activities.

Regulatory Submissions

Whether it is for PMA (pre-market) or post-market submissions, ExtraView software can help organize and manage your device or study, establishing the workflow and sign-offs needed during the approval process. ExtraView can easily manage electronic submissions and automate PDF file generation of regulatory forms such as 510K and MedWatch, making search and retrieval easy. ExtraView is web-based so it's accessible to all authorized users regardless of location. Electronic signatures can be appended automatically to each document as required by 21 CFR Part 11. ExtraView can also pull health code and reference information from sources such as IHS, WHO Drug, and MedDRA so that your data is centralized with each submission. Real-time dashboards and reporting allow 24 x 7 availably for any critical activities.

Health & Safety

ExtraView's Health and Safety template solutions help hospitals, clinical research organizations and healthcare providers centralize their high priority data collection for top quality patient care. ExtraView allows EH&S groups to maintain compliance and efficiently manage and track key processes and actions based on organizational SOPs, local, federal as well as meet international compliance guidelines. Improve benchmarks and performance criteria for slips, falls, pressure ulcers, blood transfusions, equipment temperatures, pain management, facility training and staff certifications. Give your facility insight into why performance numbers are high or low. ExtraView is the perfect platform for driving continuous improvements, including root cause analysis, corrective and preventive actions, trending and management review. Automated scheduling can track and assign training and safety assessments. Alerts can notify stakeholders when re-training and new safety procedures are required.