While Quality and the implementation of a Quality Management System (QMS) are often perceived as a costly burden, an integrated cloud-based QMS is easy to deploy, contains costs and efforts, and contributes to better and more efficient processes. With QUMAS Cloud, customers can focus on the usage of the application rather than on its management. Based on the ScienceCloud infrastructure managed by BIOVIA and built on Amazon Web Services (AWS), the responsibility for security, application access, operations, and maintenance will be removed from your IT organization freeing up valuable time, resources, and budget.
QUMAS Cloud provides easy control of costs and low Total Cost of Ownership (TCO). The BIOVIA ScienceCloud-based solution is easy to configure, deploy and integrate without a heavy IT footprint. The subscription on a yearly basis includes the costs of upgrades, support, enhancements, scalability, performance improvements and testing, providing full control of costs. QUMAS Cloud can scale from 25 users to over 100,000 with the ability to rapidly deploy additional infrastructure as needs arise.
BIOVIA takes care of delivering application and security updates and ensuring performance. You will realize reduced risk, reduced IT burden, and increased flexibility while retaining full control over frequency and timing of updates and upgrades for alignnment of your own Computer System Validation (CSV) strategy. For complete privacy, your data remains completely separate from other customers. There is no risk of data being comingled with other customers’ data.
All of the components provide built-in compliance management and support the most stringent requirements such as: 21 CFR Part 11; 210; 820; 600, ISO standards (9000; 1400), Annex 11 and GxP practices. The solution also provides immutable audit trails and full support for Electronic Signatures as per the US Food & Drug Administration (FDA) 21 CFR Part 11 requirements.
BIOVIA ScienceCloud has undergone a certification process with Securastar, an information security consulting firm specializing in ISO 27001, and Bureau Veritas that verified that a detailed framework for security design, implementation and management are in place, continuously monitored and improved. The certification process also verifies that a robust framework exists for information security risk assessment, threat identification, and rapid response.