Capabilities

Benefits

Global Deviation and Nonconformance Management

Inherit polices

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Enforce standards by enabling sites to inherit corporate polices and workflows

Web-based Forms

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Enable users in any department to capture failure/discrepancy data and initiate a CAPA

Investigations & Implementations

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Identify the root cause of an issue to eliminate problems at their source and prevent recurrence

Review Verifications

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Initiate and schedule reviews to ensure that issues have been addressed successfully

Shorten Time-to-Resolution

Workflow Management

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Route problems to the appropriate person or department to ensure rapid investigation

Electronic Material Review Board (MRB)

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Electronically convene MRBs to assess the impact of a problem and record MRB discussions

Milestones

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Schedule and manage milestone dates to ensure that investigations are closed out on time

Escalation

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Eliminate bottlenecks by automatically elevating incomplete tasks and reviews

Things-to-Do List

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Keep your entire organization up-to-date on tasks and work items needing attention

Automated Alerting

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Notify affected parties via e-mail to ensure prompt attention to tasks and CAPA issues

Search & Full Text Search on Attachments

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A variety of search capabilities help you to rapidly locate CAPA records and related information

Ensure CAPA Effectiveness

Root Cause Analysis

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Identify the true cause of a problem and determine the impact of CAPAs to prevent future occurrences

Follow-up Audits

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Integrate with SmartAudit to schedule follow-up to ensure that a CAPA was successful

Failure Mode Monitoring

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Identify adverse trends so a CAPA can be initiated before serious deviations occur

Continuous Improvement

Real-time Reporting

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Configurable reports provide instant visibility into

issues to enable informed decision and making

Personal Queries

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Users can create personalized queries to immediately analyze emerging problems

Change Management

Change Notification

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Rapidly communicate changes to ensure that your entire organization is up-to-speed

Integration with

Core Systems

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Automatically enforce changes across all affected systems to ensure consistency

SmartDoc Integration

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Ensures that changes affecting SOPs are automatically implemented

SmartAudit Integration

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Automatically schedule training to educate your workforce about changes and new processes