21 CFR Part 820, 21 CFR Part 11, EudraLex Annex 11, GAMP 5, IEC/ISO 9001, ISO 27001 compliant, and SOC II Type II certified, our cloud solutions are hosted using the most advanced and secure data infrastructure available.
PLATFORMS / SaaS
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 Lifecycle Management System.
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.
Security & Scalability
Customer data security is paramount for all ValGenesis solutions and services. This is why our cloud solutions are hosted in the most advanced and secure data infrastructure available—an SSAE 16, SOC II Type II-certified data center. This environment provides advanced security features at the network, server, and application levels to ensure our customer data is always protected. Client data is always encrypted in the cloud.Our cloud service is equipped with network redundancies, stand-by backup power, and high-bandwidth internet access. Other security features include continuous monitoring of user access, intrusion detection, and firewall integrity. These combined security assets are the reason why ValGenesis continues to boast an outstanding record of up-time and availability.
Our cloud solutions offer near limitless potential for growth and scalability. Therefore, as the needs of your organization grow and/or change, our cloud solutions can be easily scaled to accommodate them. ValGenesis also has the ability (if requested) to manage all behind-the-scenes hosting and software upgrades for our clients, and our team can provide 24/7 system monitoring through change control processes.
SOC II Type II Compliance
ValGenesis Cloud Solutions are delivered to customers using SSAE-16 and SOC II Type II certified, secured enterprise-class infrastructure and services.
ISO 27001 Certified
ValGenesis maintains a comprehensive security program based on ISO 27001, thus ensuring the confidentiality, integrity, and availability of our client data.