Fusion QbD® Software Qualification Services
Qualification Master Documentation Package (QMD Package)
S-Matrix provides three Fusion QbD Software Qualification Options:
- Self Qualification. Software qualification is performed by the customer using the S-Matrix QMD Package (see below).
- Remote (secure, web-based) software qualification. Software qualification is performed by S-Matrix via a secure web link with the active participation of a designated customer representative on site.
- On-site software qualification. Software qualification is performed by S-Matrix or a local S-Matrix certified representative on site.
Contact us for more information and documentation.
Qualification Master Documentation Package (QMD Package)
S-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. The QMD covers:
- All 21 CFR Part 11 compliance support tools and functions
- All installed Fusion Application Modules (FAMs - e.g. Fusion LC Method Development, Fusion LC Method Validation)
- All CDS Data Exchange Modules (DEMs) – e.g.:
- Agilent ChemStation/OpenLab DEM
- Thermo Scientific Chromeleon DEM
- Waters Empower DEM
S-Matrix also maintains a complete documentation set to support customer software qualification:
- 21 CFR 11 Support Assessment Report
- GAMP 5 Classification Document
- Risk Assessment Document
- Deployment Diagrams
- Detailed Installation/Setup Guides
- URS Documents for each module
Contact us for more information.