21 CFR Part 11 Compliant Cloud Hosting
- 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.
How Are We 21 CFR Part 11 Compliant Cloud Hosting?
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.
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.
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.