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Implementation of Compliance Automation Platform for Streamlined Information Security Audits in Healthcare Manufacturing
  1. case
  2. Implementation of Compliance Automation Platform for Streamlined Information Security Audits in Healthcare Manufacturing

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Implementation of Compliance Automation Platform for Streamlined Information Security Audits in Healthcare Manufacturing

eleks.com
Medical
Manufacturing
Healthcare

Inefficient Manual Internal Audit Processes in a Highly Regulated Healthcare Environment

The client faced challenges with manual internal audit processes that hindered operational efficiency for information security leaders. The organization required automation to meet stringent regulatory compliance standards (ISO27001) across 40+ controls in ten departments while maintaining data security and system validation requirements.

About the Client

French medical device manufacturer producing osteosynthesis implants for elective surgery and traumatology, operating in a highly regulated environment with strict data security and process validation requirements

Automate and Enhance Information Security Audit Efficiency

  • Implement a SaaS-based governance, risk, and compliance platform for audit automation
  • Streamline audit workflows and document management across multiple departments
  • Achieve 75% efficiency improvement in internal audit operations
  • Improve organizational understanding of information security standards and controls

Core Audit Automation System Requirements

  • ISO27001-compliant control management framework
  • Multi-department audit workflow automation
  • Centralized audit documentation repository
  • Real-time compliance reporting dashboard
  • Role-based user training modules

Platform and Framework Requirements

SaaS-based Compliance Automation Platform (eCAP)
ISO27001-certified security framework
Cloud-native document management system

System Integration Requirements

  • Existing enterprise document management systems
  • HR training management platforms
  • Departmental operational systems

Operational and Security Requirements

  • HIPAA/GDPR-compliant data security controls
  • Scalability for 40+ audit controls and 10+ departments
  • 99.9% system availability SLA
  • Multi-factor authentication and role-based access

Expected Business Transformation Outcomes

The implementation will enable 75% faster audit cycles, reduce manual documentation efforts by 60%, and provide real-time visibility into security compliance status. The solution will create formal audit evidence trails, improve cross-departmental security awareness, and ensure adherence to medical device industry regulatory requirements while maintaining operational continuity.

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