Our validated cloud system was built as per 21 CFR Part 820 requirements. In addition, it strictly follows the requirements of 21 CFR Part 11, Eudralex Annex 11, and the principals of GAMP 5 . Our cloud was also built in accordance with IEC/ISO 9001 for quality system management and ISO 27001 for information security management, for a fully robust quality system to manage compliance and security while offering exceptional support practices.
The ValGenesis Cloud Platform is designed to manage critical validation, quality/regulated data, and documents in the secured cloud. With ValGenesis’s validated cloud, users can instantly realize the benefits of a full-featured, enterprise-class Validation Life cycle Management System. System activation is instant, setup is intuitive, and the scope of the solution can be scaled to support users from a single project level to multi-site corporate levels. Your organization will experience both ease of growth and cost reductions through use of our robust, scalable and validated cloud services.