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Ensure Proper Documentation

Standardized forms and electronic workflows ensure required data is collected from initial documentation of the deviation through investigation, analysis, and resolution.

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Standardize Your Risk Assessment

Built-in risk assessment tools ensure proper immediate action is taken as well as appropriate notification and escalation of the deviation.

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Justify Planned Deviations

Document planned deviations with justification information and route for managerial approval within the system.

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Accelerate Deviation Resolution

Assign investigation tasks, collaborate on analysis and electronically route the deviation form for approval, all within the solution’s flexible workflow.

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Track and Trend

Identify trends and patterns of deviation occurrence through tagging and tracking error codes, categories, departments and more.

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Escalate High-Risk Deviations

Automated Escalations ensure proper managerial notification of high severity deviations.

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Report on Actionable Data

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

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Launch a CAPA

Generate an electronic CAPA form straight from the deviation form, automatically populating any common data onto the CAPA.

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Integrated Quality Processes

Integrated Quality Processes

Link deviations to related quality forms including non-conformance, CAPA or customer complaints.

Simplified Documentation

Simplified Documentation

Ensure all data required for cGMP guidelines is captured on the deviation record.

Accelerated Resolution

Accelerated Resolution

Automated workflows and intuitive electronic forms facilitate efficient and streamlined deviation processes.

Everything You Need Comes Standard

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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