Life Sciences Solutions

This accelerator provides comprehensive solutions for the life sciences industry, focusing on regulatory compliance, data security, and seamless integration with healthcare systems.

Overview

The Life Sciences Solutions accelerator helps organizations in the pharmaceutical, biotechnology, and medical device sectors build secure, compliant integrations that meet industry-specific requirements:

• FDA 21 CFR Part 11 Compliance
• HIPAA Requirements
• GDPR Compliance
• Data Integrity Standards
• Audit Trail Requirements

Features

Regulatory Compliance

<flow name="life-sciences-compliance-flow">
    <http:listener config-ref="HTTP_Listener_config" path="/api/life-sciences"/>
    <ee:transform>
        <ee:message>
            <ee:set-payload><![CDATA[%dw 2.0
output application/json
---
{
    complianceId: uuid(),
    timestamp: now(),
    regulatoryFramework: "FDA 21 CFR Part 11",
    controls: payload.controls,
    status: "VALIDATED",
    auditTrail: {
        userId: vars.userId,
        action: "DATA_MODIFICATION",
        timestamp: now()
    }
}]]></ee:set-payload>
        </ee:message>
    </ee:transform>
    <logger level="INFO" message="Life sciences compliance check completed"/>
</flow>

Key Features

• Automated compliance validation
• Electronic signatures
• Audit trail generation
• Data integrity checks
• Secure data transmission
• Regulatory reporting

Integration Capabilities

• EDC Systems
• CTMS
• LIMS
• ERP Systems
• Quality Management Systems
• Document Management Systems

Implementation Guide

1. Setup Compliance Framework

   • Configure regulatory requirements
   • Set up validation rules
   • Implement audit logging

2. Security Configuration

   • Enable encryption
   • Set up access controls
   • Configure audit trails

3. Integration Setup

   • Connect to source systems
   • Configure data mapping
   • Set up error handling

Best Practices

• Maintain complete audit trails
• Implement electronic signatures
• Regular compliance assessments
• Document all processes
• Regular system validation
• Data integrity checks

Reference Architecture

Support

For implementation support or questions, contact our life sciences solutions team.