About this on-demand webinar
Computer System Validation is the process of testing and validating or qualifying regulated, GxP computer systems to ensure they do exactly what they are designed to do in a consistent and reproducible manner that is safe, secure, and reliable—and generates the records to prove it. It is required by global health authorities for regulated life sciences companies, and you can’t do business without it. Validation doesn’t have to be an IT burden, and you don’t have to choose between regulation and innovation. This on-demand webinar addresses forward-thinking validation and continuous compliance considerations for modern cloud technologies.
What you’ll learn
- A solution to save time, save money, and mitigate risk across your validated environment.
- An innovative approach to validate cloud environments that enables faster GxP application deployment.
- How to think about and navigate the ever-changing global regulatory landscape.
- How to frame your own compliance maturity model.
- How the Responsibility Model divides accountability between your company as the data owner and the cloud service provider.
What’s covered in the session
The discussion includes the following topics:
- A solution to save you time, save you money, and mitigate risk
- An innovative approach to validate cloud environments to enable faster GxP application deployment
- Thoughts on how to approach the ever-changing global regulatory landscape
- Guidance on how to think about your compliance maturity model
- Q&A with subject matter experts
See a sneak peek of our webinar below, where our speakers discuss the Responsibility Model and how to break down the shared responsibility between your company as the data owner and the cloud service provider.
The USDM point of view
For regulated life sciences companies, validation is non-negotiable—but it should not be the thing that slows your move to the cloud. When you treat validation as a continuous, automated discipline rather than a one-time IT project, you can adopt modern cloud technologies and keep your GxP systems in a state of continuous compliance. A clear shared-responsibility model, a risk-based approach aligned with Computer Software Assurance, and rigorous data integrity practices let you deploy faster while still meeting the expectations of global health authorities.
Frequently asked questions
What is computer system validation and why is it required?
Computer System Validation is the process of testing and validating or qualifying regulated, GxP computer systems to confirm they do exactly what they are designed to do in a consistent and reproducible manner that is safe, secure, and reliable—and that they generate the records to prove it. Global health authorities require it for regulated life sciences companies, so it is a prerequisite for doing business. It is closely tied to 21 CFR Part 11 expectations for electronic records and signatures.
Do I have to choose between regulation and innovation?
No. The webinar makes the case that validation does not have to be an IT burden and that you do not have to trade compliance for innovation. With a forward-thinking, automated approach to validation and continuous compliance, you can adopt modern cloud technologies and still satisfy regulatory requirements.
What is the Responsibility Model discussed in the session?
The Responsibility Model breaks down the shared responsibility between your company—as the data owner—and the cloud service provider. The session walks through how to divide accountability so that nothing falls through the cracks as you validate and operate GxP applications in the cloud. Clarifying these boundaries is also central to managing third-party risk.
How does automating validation help with cloud deployments?
An innovative approach to validating cloud environments enables faster GxP application deployment while mitigating risk—saving both time and money. Rather than re-validating from scratch with every change, an automated, continuous model keeps systems compliant as they evolve, which is especially valuable for a modern, frequently updated cloud stack.
Where can I learn more after watching?
USDM also offers a condensed white paper, Automate Validation Across Your Tech Stack, covering similar content. To discuss your own validation and continuous compliance program, contact our team.
Presenters
John Petrakis
VP of Cloud Assurance, USDM Life Sciences
Stepheni Norton
Director of Product Management, Cloud and Digital Solutions, USDM Life Sciences
Watch the on-demand webinar
Press play above to watch Automating Validation Across Your Tech Stack on demand and see how USDM helps life sciences teams validate cloud environments faster. Ready to talk through your own tech stack? Contact USDM to get started.
We also have a condensed white paper – Automate Validation Across Your Tech Stack – covering similar content.