Annex 11 and GxP Compliant Cloud
By managing a complete set of system documentation since the inception of Validated Cloud, we provide full traceability for all changes to the infrastructure. Validated Cloud employs procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of Electronic Records created, modified, stored or transmitted by Validated Cloud in accordance with all of the seventeen Annex 11 and GAMP 5 requirements.
How Are We a Annex 11 and GxP Compliant Cloud?
We follow the EudraLex Annex 11 and GAMP 5 for Qualification as well 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 science company, service provider or a software company, by leveraging Validated Cloud all of the underpinning compliance that supports your validated application is in place.
At Validated Cloud, we manage our operations in accordance to a 21 CFR Part 820 and ISO 9001 Quality system which minimizes risk of changes and ensures that 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 meeting 21 CFR Part 11, Annex 11, and GAMP 5 requirements.
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.