As your organization’s IT infrastructure becomes more sophisticated, you need strategic controls around qualification and validation.
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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.
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
- 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.
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.
Compliance doesn’t have to be a burden—explore outsourcing options in this white paper > > >
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.
Harmonize compliance and innovation. Download this white paper to learn how > > >
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.