The Fusion QbD® Software Platform (Fusion QbD) contains the e-signature and e-record controls required to support full regulatory compliance for a closed system under 21 CFR Part 11. To be fully compliance supporting, the required controls are substantially beyond just those for logon access to the software system, and include measures designed to ensure the integrity of all system operations and information stored in the system. Such measures include ability to validate software operation and also use of computer-generated, time-stamped audit trails. Such auditing must extend to data exchanges with other closed-system compliant applications such as Chromatography Data Software (CDS). As an example, when Fusion QbD exchanges data with a CDS system, it automatically generates electronically time-stamped audit documentation which it records within its own audit trail and also enters into the electronic audit trail of the CDS so as to maintain the integrity and audit trail of the common data between the two software systems.
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The Fusion QbD Software Platform has been verified as Citrix Ready™. Fusion QbD has been verified as compatible with Citrix XenApp environments. This provides our customers with vitally needed flexibility and support for their sitewide, enterprise, and global deployment strategies.
Request InformationS-Matrix creates a Software Qualification Master Documentation Package (QMD Package) for each release version of Fusion QbD. The QMD contains all documents, testing plans, and data sets required to fully qualify Fusion QbD software installation and operation in customer environments.
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S-Matrix develops advanced and innovative Quality by Design software. Our Fusion QbD Software Platform incorporates expert-system guided statistical Design of Experiments (DOE) and multivariate data analysis/modeling technologies within a Quality by Design (QbD) framework.