Designed for Regulators Trusted by Teams

Built to support inspections, audits, and global pharmacovigilance compliance with complete transparency and control.

Regulatory Compliance & Inspection Readiness

Proven Compliance. Complete Transparency. Always Inspection-Ready

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Global Standards Alignment

Built-in compliance with ICH E2A, E2B (R3), E2C, and E2D standards, ensuring standardized case processing reporting.

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GVP & Part 11 Compliance

Supports EMA Good Pharmacovigilance Practices (GVP) and FDA 21 CFR Part 11 requirements.

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Regional Regulatory Support

Flexible configuration to meet country-specific and authority-specific regulations (EMA, FDA, MHRA,etc).

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Inspection-Ready Outputs

One-click generation of inspection ready reports, line listings, case histories, narratives, minimizing manual effort.

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End-to-End Traceability

Complete traceability linking cases, signals, assessments, aggregate reports, enabling inspectors to follow the full safety decision.

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Inspection & Audit Support

Dedicated support for regulatory inspections and audits, including document retrieval, question tracking, and historical inspection.

Validation, Change Control & Auditability

Validation, Change Control & Auditability

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CSV Compliance

End-to-end support for Computer System Validation, including structured documentation

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IQ/OQ/PQ Management

End-to-end support for Computer System Validation, including structured documentation

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Change Control

All system configurations and changes are managed through controlled change workflows.

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Audit Trails

Complete, immutable audit trails capturing data changes, configuration updates, user.

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Bulk Data Changes

Supports controlled bulk updates through predefined workflows, ensuring validation, review.

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Validation Status

Provides visibility into validation status, open changes, and compliance indicators.

1

CSV Compliance

End-to-end support for Computer System Validation, including structured documentation

2

IQ/OQ/PQ Management

End-to-end support for Computer System Validation, including structured documentation

3

Change Control

All system configurations and changes are managed through controlled change workflows.

4

Audit Trails

Complete, immutable audit trails capturing data changes, configuration updates, user.

5

Bulk Data Changes

Supports controlled bulk updates through predefined workflows, ensuring validation, review.

6

Validation Status

Provides visibility into validation status, open changes, and compliance indicators.

1

CSV Compliance

End-to-end support for Computer System Validation, including structured documentation

2

IQ/OQ/PQ Management

End-to-end support for Computer System Validation, including structured documentation

3

Change Control

All system configurations and changes are managed through controlled change workflows.

4

Audit Trails

Complete, immutable audit trails capturing data changes, configuration updates, user.

5

Bulk Data Changes

Supports controlled bulk updates through predefined workflows, ensuring validation, review.

6

Validation Status

Provides visibility into validation status, open changes, and compliance indicators.

Implementation, Validation & Ongoing Support

Ensures compliance is embedded from implementation through validation, ongoing operations, and continuous regulatory change.

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Requirements & Solution Design

Structured requirement assessment and solution design aligned with regulatory expectations and SOPs.

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SOP-Aligned Configuration

System configuration mapped directly to approved SOPs, ensuring operational fit without compromising compliance.

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Validated Data Migration

Secure data migration with reconciliation, validation, and documented evidence to ensure data integrity and continuity.

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Training & User Onboarding

Role-based training and onboarding to support compliant system usage and inspection readiness.

Immutable Audit Trails

Automatically captures all critical data actions with user ID, timestamp, old and new values.

Data Accuracy & Validation Controls

Built-in validation rules, controlled fields, and workflow checks reduce errors and ensure data consistency across cases.

Regulator Grade Data with Enterprise Level Protection

Accurate, Complete, and Traceable Data Across the Safety Lifecycle . Ensuring data reliability from initial capture through assessment, reporting, submission, and long-term archival, with full transparency.

Segregation of Duties

Separates critical tasks across roles to prevent conflicts of interest and ensure compliance.

Regional Policy Enforcement

Applies country-specific security and governance rules automatically based on regulatory requirements.

Controlled Access and Protection of Safety Data

Safeguards confidential safety information through role-based access, segregation of duties, and auditable security mechanisms aligned with regulatory expectations.

Secure Connectivity Across the Safety Ecosystem

Enables seamless, compliant, and secure data exchange

EDC & CTMS Reconciliationarrow

Medical Information Integration

Partner & License Exchange

Regulatory Gateway Connectivity

E2B (R3) Data Exchange

Secure APIs & Controlled Exports

Automated reconciliation of safety data with EDC and CTMS systems to identify discrepancies, ensure completeness, and maintain consistency.

Automated reconciliation of safety data with EDC and CTMS systems to identify discrepancies, ensure completeness, and maintain consistency.

Flexible Operations with Built In Compliance Control

Enables operational teams to adapt workflows, timelines, and templates while maintaining full regulatory control

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Faster Workflow Adaptation

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Reduction in SLA Breaches

Operational Card 1

Configurable Workflows

Design and manage workflows by product, study, region, and case type to support diverse operational needs without code changes.

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SLA Management & Escalation

Define, monitor, and enforce regulatory and operational SLAs, with automated alerts and escalations to ensure timely compliance.

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Case Lifecycle Configuration

Configure case statuses, transitions, and checkpoints to align with organizational processes and regulatory expectations.