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USDM Designs AWS Data Lake to Standardize GxP Data Management Processes


Learn how USDM helped a global biotechnology company reduce maintenance, security, and compliance costs by implementing a single centralized data platform that is GxP and GDPR-compliant.

The Situation:

A global biotechnology company focused on developing antibody therapeutics for cancer treatment was looking to advance its digital transformation journey and improve business outcomes. With four global offices and over 1000 employees, they faced potential audits and inspection risks.

Some of the critical challenges faced by the customer were the need for clearer and consistent data governance and the need for more standardization in the data management process. Another critical challenge was the data security and integrity of regulated clinical trials and biomarker data. Overall, the customer faced issues with data democratization.

The Solution:

To address these issues, USDM helped the customer to standardize its data management process by implementing a data lake. A data lake is a centralized repository that allows companies to store all their structured and unstructured data at any scale. USDM’s team of experts implemented and fully validated the AWS S3 and AWS Data Lake, providing the customer with a single centralized platform, which helped reduce maintenance, security, and compliance costs.

The Results:

USDM established the required GxP and GDPR-compliant platform for the customer, with integrity and security built into the architecture to enhance transparency and compliance for data science and data mining. USDM helped the customer establish a single source of truth to enable consistent and reliable insights. The customer can better identify new opportunities and drive growth by enabling data democratization, analytics, and insights.

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