Learn how USDM enabled a GxP compliant cloud content management solution for a global biosciences company with an aggressive submission deadline.
In stage II of their clinical trials, a global biosciences company needed rapid validation of their new Box GxP environment in preparation for a Food and Drug Administration (FDA) submission. They had highly complex security requirements and aggressive timelines. The company was founded in China and has locations in the United States, developing infectious disease treatments (including COVID-19).
- The customer required assistance with configuration and continuous validation of their new Box instance to house regulated GxP data in preparation for an FDA submission.
- Box, a cloud content management system, would serve as the gateway for secure data exchanges between collaborators and SAS prior to submission.
- The customer had very limited Computer System Validation (CSV) and GxP regulatory experience.
- Validation was required for the global platform on a very aggressive timeline that involved stakeholders in China and the U.S. for execution and document review.
- Data loss prevention, data storage, and computer power needed to be adapted and implemented for their current platform.
- Security requirements traditionally handled by VPN, SFTP, and VLANs needed to be adapted and implemented.