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Development of an Automated Internal Audit Management System for Enhanced Compliance and Efficiency
  1. case
  2. Development of an Automated Internal Audit Management System for Enhanced Compliance and Efficiency

Development of an Automated Internal Audit Management System for Enhanced Compliance and Efficiency

eleks.com
Medical

Challenges in Internal Audit Processes for Regulated Medical Manufacturing

The organization faces inefficiencies in conducting and documenting internal security and compliance audits across multiple departments, leading to increased operational workload, potential compliance gaps, and difficulty maintaining up-to-date records in a complex regulatory landscape.

About the Client

A mid-sized medical device manufacturing company operating in a highly regulated environment that requires robust data security, process standardization, and compliance management.

Goals for Improving Internal Audit Efficiency and Compliance Oversight

  • Automate and streamline the internal audit process to significantly reduce manual effort.
  • Achieve an estimated 75% increase in internal audit operational efficiency.
  • Enhance documentation, tracking, and reporting capabilities for compliance controls across multiple departments.
  • Facilitate better understanding and adherence to relevant security standards such as ISO27001.
  • Provide formal evidence of control execution for audit and regulatory review purposes.

Core Functionalities for Audit Automation Platform

  • Evaluation and definition of an optimal list of compliance controls aligned with relevant standards (e.g., ISO27001).
  • Automation of audit workflows across multiple organizational departments.
  • Document management system for storing and retrieving audit evidence and control documentation.
  • User role management and training resources for various stakeholder groups.
  • Data upload capabilities for existing audit data and control evidence.
  • Configurable control monitoring dashboards and status indicators.
  • Generation of audit reports and compliance certificates.

Technological Foundations and Architecture Preferences

SaaS cloud platform for scalable, remote access
Automated workflows and process orchestration tools
Role-based access control and user management modules
Secure data storage and transmission protocols

External Systems and Data Source Integrations Needed

  • Existing security information and event management (SIEM) systems for control evidence input
  • Corporate documentation repositories
  • Regulatory compliance databases for standards mapping
  • Single sign-on (SSO) and identity providers

Critical Non-Functional System Requirements

  • System scalability to support multiple departments and up to 100+ users.
  • Performance optimized to enable audit completion within standard timeframes (e.g., under X minutes per audit).
  • High security standards including data encryption and user authentication.
  • System availability and uptime target of 99.9%.
  • Ease of use with intuitive interface to reduce training time.

Business Benefits and Expected Outcomes from Implementation

The deployment of an automated audit management platform is projected to improve internal audit efficiency by approximately 75%, reduce manual effort, improve compliance documentation standardization, and provide real-time insights into security controls across the organization, thereby strengthening overall regulatory adherence and operational resilience.

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