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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.
Key Features
- Web-based - Connect internal users, customers, vendors, and others outside the company whom can access a CAPA form. Standard web browser access with no client software to install. Unlimited number of role-based layouts, views, queries and options. All the layouts are configurable to your specification
- Configuration – Link your Corrective Action and Preventive Action (CAPA) form directly to other forms (for example, customer complaints, audit findings, etc.), thus streamlining the CAPA process. Links are maintained so users can review a completed process and easily see what triggered any CAPA. Hold multiple forms or departmental CAPA projects within a single database. Add an unlimited number of custom fields and an unlimited number of user roles
- Workflow Management - Relevant data can be automatically entered into a CAPA form, reducing data entry and eliminating errors from manual input of the information. 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 Adobe 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 - Remote and traveling users can also receive alerts and complete forms pertaining to the Corrective Action and Preventive Action (CAPA) process. Automatic and rule based notifications upon record updates. Alerts and update can be sent and received through standard company email. Reports can be scheduled and sent by email on a periodic basis
- 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
- 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.
Key Benefits
- 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 though 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 by using 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
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