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Root Cause Analysis Solutions

ExtraView is used by leading companies around the world to investigate and fix the root causes of everyday incidents, major accidents, minor near-misses, quality issues, human errors, maintenance problems, adverse events, production issues, manufacturing mistakes, and environmental issues. Capture problem data to improve operations and develop root cause analysis.

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 - Allows subject enrollment, data submission and validation for use by clinicians and research associates as well as Query Management and Bulk Data Import. Workflow may be defined for each role, form and project. Rule workflow administration allow for validation of data and processes
  • Reporting – Create and save public or private 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 converted into Microsoft Word, Microsoft Excel or PDF formats
  • 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

  • Decrease cycle time and production/operation costs by increasing deviation management efficiency
  • Increase deviation management transparency through automated alerts and extensive reporting capabilities featuring dashboards and executive overviews
  • Increase accountability through assignments, process step approvals and audit trails
  • Reduce the risk of lost or incomplete data through a closed-loop deviation management process
  • Decrease the risk of repeating errors and issues by improving root cause analysis that uses built-in decision trees and drill-down selection lists
  • Facilitate compliance with pharmaceutical and biotech industry regulations including ISO 9001 and 14001; 21 CFR Parts 11, 210 and 211; ISO/IEC 17025:2005 and other international standards
  • Integrate your deviation management system with other enterprise-level control systems such as enterprise resource planning (ERP) systems, manufacturing execution systems (MES), batch release systems and regulatory reporting systems