Enterprise Content Management System Enhancement for Regulated Industries

The organization faces difficulties maintaining a secure, compliant, and efficient document management environment across multiple departments, particularly in meeting strict industry regulations such as GAMP, FDA Title 21 CFR Part 11, and GDPR, while supporting a large user base and extensive document repository.

A large healthcare organization seeking a compliant and scalable ECM platform for document governance, process automation, and regulatory adherence.

• Develop a scalable, enterprise-level ECM platform capable of supporting up to 30,000 daily users and managing over 40 million documents.
• Implement functionalities for document and case handling aligned with predefined regulatory and operational processes.
• Integrate tools for collaborative work, including creation, approval, and distribution of electronic documents.
• Establish detailed logging and audit trail features to support compliance and security audits.
• Ensure the system is adaptable for ongoing updates in workflows and regulatory requirements.
• Support deployment options including on-premises, cloud, and mobile environments to facilitate Bring-Your-Own-Device (BYOD) policies.
• Design for full compliance with industry-specific standards and laws such as SOX, ISO, GDPR, and patient data security laws.

• Document and case handling aligned with predefined workflows
• Tools supporting collaboration, creation, approval, and electronic distribution of documents
• Administrator toolkit for designing, adjusting, and deploying processes
• Detailed user activity logs and audit trail capabilities
• Support for compliance with GAMP, FDA CFR 21 Part 11, EU Annex 11, and GDPR
• Configurable dashboards and reporting suite based on quality metrics
• Preconfigured workflows for system adaptation and ongoing process enhancement
• Multi-browser support and intuitive user interface
• Deployment flexibility supporting on-premise, cloud, and mobile environments

• Regulatory compliance systems and external audit platforms
• Identity and access management solutions
• Existing enterprise ERP or workflow management systems
• Notification and mobile access systems

• Ability to support large-scale deployment with at least 30,000 concurrent users
• High performance with quick load times and transaction processing
• Robust security features including data encryption, access logs, and audit trails
• System availability of 99.9% uptime
• Scalability to handle over 40 million documents with efficient retrieval and indexing
• Compliance with applicable industry regulations and standards

The developed ECM platform is expected to significantly enhance regulatory compliance, operational efficiency, and document governance capabilities. It aims to support business growth by accommodating large user bases and extensive document repositories while ensuring security and audit readiness, ultimately leading to improved customer confidence and streamlined certification processes.