21 CFR Part 11 Compliant Cloud Hosting

Validated Cloud’s FDA 21 CFR Part 11 compliant cloud provides its customers with the benefits of cloud solutions without putting their ability to stay compliant with FDA regulations at risk. As a full-service provider, Validated Cloud manages all aspects of a fully defendable qualified platform. The Validated Cloud service delivery team keeps the systems in compliance with our managed security and experienced GxP support. The service is designed to be always GxP audit-ready for customers or government regulators. Validated Cloud is dedicated to the life sciences, and does not cater to any other industry. This focus allows us to be the trusted subject matter experts and partner any company needs when venturing into GxP infrastructure and ongoing support.

  • Owned and managed by experienced Life Science professionals
  • Created and continuously operated in alignment US and EU Regulations
  • Governmental Regulatory Audit Defense is at the core of our service

Validated Cloud is a Life Science Services Company built for our industry 

What does GxP mean to Validated Cloud? Validated Cloud’s quality system was built in accordance with 21 CFR Part 820. We then incorporated the requirements of 21 CFR Part 11 and EudraLex Annex 11, and the principals of GAMP 5. In addition, we fully integrated IEC/ISO 9001 for quality system management, ISO 27001 for information security management and 45 CFR Part 164 for HIPAA, for a fully robust quality system to manage compliance and security and offer exceptional support practices.

Founded on the fundamentals of FDA compliance, and grown into EU regulatory requirements and international standards, Validated Cloud constantly evaluates its compliance both from external and internal audit mechanisms. By using Validated Cloud as your GxP-compliant cloud partner, we’ll allow you to focus on your company’s goals.

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21 CFR Part 11 Compliant Cloud Hosting

Validated Cloud gives you the 21 CFR Part 11 compliant cloud hosting platform that can be used to house any type of FDA-compliant data, from SaaS applications to aging validated systems.
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How Are We 21 CFR Part 11 Compliant Cloud Hosting?

All Validated Cloud activities and procedures are operational in accordance to a 21 CFR Part 820 compliant Quality system.
Validated Cloud is managed under a quality system that makes extensive use of SOPs, which are internally and externally audited and updated regularly when needed.
Validated Cloud is managed under a quality system that makes extensive use of SOPs, which are internally and externally audited and updated regularly when needed.
Validated Cloud’s private cloud observes the FDA predicate rule for qualification of the infrastructure. The Quality system and change controls make Validated Cloud the right partner for a compliant hybrid cloud.
All Validated Cloud SOPs and non-customer-specific documentation are fully auditable, as is our data center.

Secure 21 CFR Part 11 Compliant Cloud Hosting

Compliance

By following the FDA predicate rule for qualification, as well as staying compliant with 21 CFR Part 11, we ensure that your GxP application is always hosted in an environment that doesn’t put your data at risk. Whether you are a life sciences company, service provider or software company, by leveraging Validated Cloud, all the underpinning compliance that supports your validated application and data are in place. Validated Cloud fits into and accelerates pharmaceutical validation services.

Stop Qualifying System by leveraging our 21 CFR Part 11 compliant cloud hosting

Quality System

At Validated Cloud, we manage our operations in accordance with a 21 CFR Part 820 quality system, which minimizes risk of changes and ensures all appropriate procedures are followed. Our focus on quality means that your systems are protected from ad hoc changes and the outages that result from them. The environment is fully qualified since inception to meet 21 CFR Part 11 and EudraLex Annex 11 requirements and traceability for U.S. and European compliance.

21 CFR Part 11 compliant cloud hosting is a time and money saver for your business

Our Cloud – Your Business

With Validated Cloud as your 21 CFR Part 11-compliant cloud-hosting provider, you can be sure that your FDA-compliant business is built on the best available technology and compliance platform. Validated Cloud is managed by industry experts, and operates under a formal change control process with risk assessments and CAPA.

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21 CFR Part 11 Compliant Cloud Hosting

Validated Cloud gives you a 21 CFR Part 11-compliant cloud-hosting platform that can be used to house any type of FDA-compliant data, from SaaS applications to aging validated systems.
Contact Us
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