Strategic Controls for Qualification and Validation as Your Tech Stack Grows
As your organization’s IT infrastructure becomes more sophisticated, you need strategic controls around qualification and validation. The U.S. Food and Drug Administration (FDA) encourages the use of automation and new cloud technologies when employing the Computer Software Assurance (CSA) methodology for validation. CSA aims to improve process and product quality using a true risk-based approach.
What’s Inside
- How cloud computing changes change control, impact assessments, and regression testing—and where traditional approaches fall behind.
- USDM’s building-block methodology for cloud compliance, including USDM Cloud Assurance, the Compliance Matrix, identity and access management, agile compliance, and the Cloud Assurance Digital Experience web app.
- Why the building-block approach is both Computer System Validation (CSV) and CSA agnostic, and how validated blocks become reusable across applications, services, and microservices.
- The evolution of compliance automation—from documentation-heavy CSV to risk-based validation to CSA to Cloud Assurance with automated testing.
- How automated testing, continuous monitoring, and impact assessments increase the ROI of your GxP technology.
The Evolution of Compliance Automation
Cloud computing may introduce a few challenges to validation. Will your traditional change control processes keep up with change impact assessments and regression testing? How will you gain visibility into the change process? Do your internal teams have the time and expertise for change management?
To help your organization adapt its regulated workloads to the cloud, USDM provides services that create a building block approach for cloud compliance, which includes:
- USDM Cloud Assurance
- USDM’s Compliance Matrix
- Identity and access management, a core life sciences cybersecurity control
- Agile compliance
- Cloud Assurance Digital Experience web app
This building block methodology helps you automate and control your tech stack when it feels uncontrollable. The methodology is also Computer System Validation (CSV) and CSA agnostic.
With this approach, when you qualify a server and the operating system of cloud service providers, it doesn’t require additional qualification and validation when you add another application. Change control is run on blocks that are already validated and qualified. Services and microservices are additional blocks in the tech stack. All of these blocks become reusable and automated change control helps to simplify the validation process. Building these controls on a foundation of data integrity and 21 CFR Part 11 compliance keeps your regulated systems audit-ready as they scale.
Compliance automation has evolved from:
Computer System Validation with an emphasis on documentation
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Risk-based approach
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Computer Software Assurance methodology that supports automation
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Cloud Assurance, which includes automated testing
Automated testing saves your organization time and money—and minimizes human error—because it’s fast, efficient, and accurate. Using an automated compliance framework, USDM Life Sciences enables compliant change control with features like continuous monitoring, impact assessments, and updated automated tests for new releases and system updates.
Increase ROI of GxP Technology with Automation
USDM Cloud Assurance delivers unparalleled regulatory compliance with built-in automation. It unburdens your organization of initial validation and ongoing compliance maintenance. As your GxP tech stack grows, automated workflows and testing help to support your business goals.
To access the results of automated testing and to schedule regression testing for supported applications, USDM developed the Cloud Assurance Digital Experience (Dx) web app. It simplifies your compliance efforts with always-on transparency and access to all of your systems.
The USDM Point of View
In life sciences, validation can’t be a one-time event that stalls every cloud release. USDM’s position is that compliance should be engineered as reusable, automated building blocks—qualify once, reuse everywhere—so that change control, regression testing, and impact assessments keep pace with the cloud instead of blocking it. Because the approach is CSV and CSA agnostic, you adopt the FDA’s risk-based Computer Software Assurance direction without rebuilding your quality system, turning ongoing compliance from a cost center into a source of speed and ROI. The same risk-based, automation-first mindset extends naturally to emerging areas like AI governance and compliance as your regulated tech stack evolves.
FAQ: Automating Validation Across Your GxP Tech Stack
What is Computer Software Assurance (CSA) and how does it relate to validation?
CSA is a methodology the FDA encourages for validating software, using a true risk-based approach to improve process and product quality. It supports the use of automation and new cloud technologies, and it represents an evolution from documentation-heavy Computer System Validation (CSV) toward risk-based, automation-friendly assurance. Learn more about Computer Software Assurance (CSA).
What is the building-block approach to cloud compliance?
It is a methodology where each layer of your tech stack—servers, operating systems, applications, services, and microservices—is validated and qualified as a reusable block. Once a block is qualified, adding another application doesn’t require re-qualifying everything beneath it; change control runs on blocks that are already validated, and automated change control simplifies the process.
Is this approach tied to CSV or CSA?
No. The building-block methodology is both CSV and CSA agnostic, so it fits your existing quality system regardless of which validation framework you follow.
How does automated testing reduce compliance cost and risk?
Automated testing is fast, efficient, and accurate, which saves time and money while minimizing human error. Within an automated compliance framework, it enables compliant change control through continuous monitoring, impact assessments, and updated automated tests for new releases and system updates.
What is the Cloud Assurance Digital Experience (Dx) web app?
It is a web app USDM developed so you can access automated testing results and schedule regression testing for supported applications. It simplifies compliance with always-on transparency and access to all of your systems. See USDM Cloud Assurance for the full managed compliance offering.
USDM’s best practices and test automation capabilities significantly decrease your implementation and validation time. Contact us today to automate validation across your tech stack.