On-Demand Roundtable
Join USDM Life Sciences and Oracle for an educational discussion about moving to the Cloud and addressing the technology and regulatory requirements in the life sciences industry. The agenda includes an update on the FDA's new Computer System Assurance (CSA) guidance and how USDM and Oracle have developed a joint solution that provides assurance that Oracle Cloud can be validated.
Learn how your colleagues are leveraging Oracle SCM, USDM Cloud Assurance, and Oracle validation best practices and tips on how to reduce compliance costs and take advantage of Oracle's Cloud suite to streamline your business.
What You'll Learn
- How the FDA's Computer System Assurance (CSA) guidance reshapes the way life sciences companies validate cloud software.
- How USDM and Oracle developed a joint solution that provides assurance that Oracle Cloud can be validated for regulated use.
- How organizations are leveraging Oracle SCM together with USDM Cloud Assurance to stay compliant in the cloud.
- Oracle validation best practices and practical tips for reducing compliance costs.
- How to take advantage of Oracle's Cloud suite to streamline business operations without sacrificing regulatory readiness.
Why this matters: Moving regulated workloads to the cloud raises a fundamental question for life sciences companies — can a continuously updated SaaS platform stay validated? USDM's view is that a risk-based assurance approach, aligned to the FDA's CSA thinking and paired with USDM Cloud Assurance, lets teams adopt Oracle Cloud with confidence while reducing the validation burden rather than adding to it.
About the Presenters
Stepheni Norton, Director of Product Management, Digital and Cloud Solutions
David Blewitt, Vice President of Cloud Compliance
Todd Hein, Executive Director of Life Sciences, Oracle
Frequently Asked Questions
What is Computer System Assurance (CSA) and how does it relate to Oracle Cloud?
CSA reflects the FDA's risk-based approach to validating computerized systems, emphasizing critical thinking and testing effort proportional to risk. In this roundtable, USDM and Oracle discuss how that guidance applies to validating Oracle Cloud for life sciences use. Learn more about Computer Software Assurance.
Can Oracle Cloud be validated for regulated life sciences environments?
Yes. The session covers how USDM and Oracle developed a joint solution that provides assurance that Oracle Cloud can be validated, so regulated organizations can adopt Oracle's Cloud suite while meeting technology and regulatory requirements.
What is USDM Cloud Assurance?
USDM Cloud Assurance is USDM's managed service for keeping cloud applications continuously validated and compliant as they are updated. See USDM Cloud Assurance for details on how it supports platforms like Oracle Cloud.
How can moving to Oracle Cloud reduce compliance costs?
The roundtable shares Oracle validation best practices and tips on leveraging Oracle SCM and USDM Cloud Assurance to streamline compliance work and reduce the cost of staying validated in the cloud.
How does this relate to 21 CFR Part 11?
Cloud systems used in regulated life sciences processes must satisfy electronic records and signatures requirements. Explore how these expectations apply in our overview of 21 CFR Part 11 compliance.
Watch the on-demand roundtable to hear USDM and Oracle discuss validating Oracle Cloud for life sciences. Have questions about validating your Oracle environment or adopting USDM Cloud Assurance? Contact us to talk with our team.