S-Matrix Corporation services
S-Matrix Analytical Development Labs Services
Major Pharmaceutical companies worldwide use our Fusion QbD® Software Platform (Fusion QbD) every day to successfully develop truly robust and transferrable methods, including enterprise deployments at more than half of the world’s largest pharmaceutical companies. In addition, regulatory agencies use Fusion QbD to modernize methods and to challenge robustness claims in Pharma company submittals!
Consulting Services
S-Matrix Consulting can ensure proper use of your Fusion Pro product or your Fusion QbD product module(s) to successfully implement Design of Experiments (DOE) methodology. S-Matrix experts can advise and assist you with any and all aspects of project planning, experiment design, data analysis, historical data mining, as well as interpretation and reporting of results, which will enable you to decrease product or process development time. Contact us at 707-441-0406 or sales@smatrix.com to discuss your consulting requirements and to request a quotation.
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.
Regulatory Compliance Consultants Services
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).