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.
From the onset, Validated Cloud maintains comprehensive system documentation, offering complete traceability for infrastructure changes. We implement stringent procedures to guarantee the authenticity, integrity, and confidentiality of Electronic Records in line with all Annex 11, GAMP 5, and global regulations. Our sole dedication to the life sciences and ownership by seasoned Life Science professionals means we’re not just another provider but a trusted expert in GxP infrastructure and ongoing support. We ensure your systems are always GxP audit-ready, whether for internal review or governmental scrutiny. With Validated Cloud, you get a partner deeply rooted in regulatory adherence, enabling you to prioritize your objectives.
How Are We 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, Annex 11 and GAMP 5, we ensure that your GxP applications are 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.
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.
Our Cloud – Your Business
Validated Cloud is your Annex 11, 21 CFR Part 11 and GxP compliant cloud hosting provider. Life Science EU and US compliant systems deserve the best available technology and compliance platform available. Validated Cloud is managed by experienced industry experts. We operate under a formal change control process with a full risk assessment program and CAPA system.