Fusion QbD® 21 CFR Part 11 Compliance Support

Regulatory Compliance

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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Customer and Instrument/CDS Vendor Partner Audits

S-Matrix Corporation has successfully passed on-site audits conducted by major International Pharmaceutical Company customers and Instrument/Software Vendor partner companies, and also successfully passed remote (document-based) audits by major International Pharmaceutical Company customers. In all cases these audits addressed all of our business practices and supporting systems, including our software development life cycle model and software development best practices, our software and document version control systems, our personnel management and training programs, our backup and disaster recovery systems, and our business processes systems. S-Matrix Corporation has never failed a customer or partner audit.

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