Business Need
The client faced significant challenges in building a compliant, secure, and scalable drug development platform:
- Navigating stringent compliance standards, including FDA 21 CFR PART 11, HIPAA, and GDPR.
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Managing complex validation and testing workflows across multiple teams.
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Providing seamless integration with enterprise systems to improve collaboration and efficiency.
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Addressing the need for a robust customer support solution to manage user inquiries effectively.
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The client required a solution that met compliance and quality standards while streamlining operations and ensuring scalability for future needs.
The Approach
AlgebraIT employed a strategic and collaborative approach, focusing on:
- Conducted stakeholder discovery sessions to align platform goals with compliance and business needs.
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Established documented compliance frameworks to meet regulatory standards.
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Developed a scalable architecture utilizing Azure services, SharePoint, Dataverse, and Cosmos DB.
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Developed a scalable architecture utilizing Azure services, SharePoint, Dataverse, and Cosmos DB.
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Implemented low-code/no-code solutions using Microsoft Power Platform and O365 tools.
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Designed manual, automated, and CSV validation workflows to ensure accuracy and reliability.
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Deployed Zendesk to create a seamless customer support system.
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This approach ensured a balance between innovation, compliance, and operational efficiency.
The Solution
AlgebraIT delivered a tailored drug development platform with the following features:
- A compliant End-to-End Platform built using Azure, SharePoint, and Dataverse, with Cosmos DB for scalability.
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Integration with Microsoft Power Platform for process automation, data visualization, and workflow optimization.
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Robust validation workflows adhering to CSA guidelines to eliminate inefficiencies.
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A secure customer support system powered by Zendesk to improve user interaction and query resolution.
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Reusable, scalable components to facilitate future module expansion with minimal rework.
Benefits
The project delivered meaningful results:
- Fully operational, PART 11-compliant software product meeting all specifications.
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60% Improvement in compliance adherence due to robust frameworks and automated processes.
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40% Increase in operational efficiency through streamlined workflows and cloud-based architecture.
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30% Reduction in validation and testing timelines with automated workflows.
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Enhanced user satisfaction with a Zendesk-powered customer support system.
Future-proofed architecture supporting scalable integrations and reusable components.
Visuals
Functional Overview
Architectural View
