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ExtraView's solution for Change Control is designed to help both ISO and FDA-regulated manufacturers automate and effectively manage every step of the change control process, from design through implementation, and verification. ExtraView can integrate with ERP systems to streamline the entire change control procedure for faster turn-around. Real-time reporting allows for escalation of issue and alerts. Capture changes and attach documents to follow SOP's to simplify your process controls. The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements, prompting risk assessment. The solution may also ask for information such as the classification of the change as a low, medium, or high priority.
Key Features
- Web-based - Standard web browser access with no client software to install. Unlimited number of role-based layouts, views, queries and options
- Point-and-click 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. Simple workflow administration allows for the 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
- 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
- Consolidate multiple systems into a central management system that lets you control a central knowledgebase
- Make sure actions, tasks and information reviews are managed and completed on time
- Manage safety data centrally to improve efficiency
- Control the quality of information available to staff
- Facilitation of risk assessments in one standard format
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