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Enhancing Regulatory Compliance with Argus Safety Database

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Learn how USDM ensured audit readiness for a global biotech company.

A global biotech company required initial validation of the Argus Safety database and data migration from their legacy database. However, the company did not have an internal validation lead to oversee the validation process for Argus. The project required special expertise in transferring Argus data from the legacy organization, which added a level of complexity to the project.

To address their needs, the company engaged USDM Life Sciences (USDM) to handle the validation and data migration tasks. Despite challenges, the legacy data was successfully transferred to the new database, minimizing the risk of data loss and discrepancies. In addition, USDM developed a Validation Master Plan for the company to ensure that the new Argus Safety database met Good Documentation Practices and data integrity principles.

Working with USDM, the company was well prepared for its post-implementation audit by the FDA. This successful project allowed the company to confidently move forward, knowing they were fully prepared to navigate the complex regulatory landscape.

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