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Collect the Right Information

Intuitive complaint intake forms facilitate accurate documentation of complaints through required fields and automated workflows.

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Document the Impact Assessment

Flexible drop-down options and data lists enable the collection of serial number, lot number or other product identifiers, facilitating traceability.

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Control Risk

Standardized risk assessment tools configured to your organization’s risk profile enable consistent categorization of the severity of complaints.

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Escalate High Risk Complaints

Automated Escalations ensure proper managerial notification and prioritization of critical complaints.

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Accelerate Complaint Investigation & Resolution

Electronic workflows and task generation accelerate complaint response time and reduce investigation bottlenecks.

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Perform Trend Analyses

Coding and categorization tools enable tracking and trend analysis on historical complaints, facilitating continuous quality and safety monitoring.

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Report on Actionable Data

Permission-based reporting on real-time and historical complaint data keeps you inspection-ready and supports overall quality improvement efforts.

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Launch a CAPA

Generate a CAPA form from a high risk complaint right from the complaint form or from an adverse trend identified by recurring complaints.

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Streamlined Complaint Processes

Streamlined Complaint Processes

Automated workflows ensure complaints are recorded, assessed and resolved in a timely manner.

Increased Visibility

Increased Visibility

Management can track, trend, and report on complaint data through a centralized system at leach location and across the enterprise.

Improved Patient Safety

Improved Patient Safety

Built-in risk assessment tools ensure threats to patient safety are escalated and quickly acted upon.

Everything You Need Comes Standard With The Software

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Flexible Best-in- Class Forms & Workflows

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Personalized Dashboards

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21 CFR Part 11 Compliant E-Signatures

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Searches & Queries

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Email Integration

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Role-based Permissions Management

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Centralized Reporting

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Full Audit Log

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Validation Documentation

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Security & Data Access Control