SXI’s services and products can provide the support your company needs in the following scenarios:

Relieve resource pressure by having SXI resource your flagship or sustaining project.
Build & Qualify custom software tools to automate your workflow and your testing.
Augment your team and provide mentorship and technical expertise to train your team.
Evaluate your current process to establish regulatory compliance and provide a roadmap on how to improve your process to become efficient and effective.

Services include:

Verification & Validation [IEC/ISO/IEEE 12207, IEEE 1210, ISO/TR 80002-2]
Computer System Validation [GAMP 5]
Process Validation
Spreadsheet Validation
Database Validation
Workflow Automation
Test Case Automation
Test Tool Development
Metrics – KPI Tool Development
Process Improvement [CFR Regulation / Agency Guidelines / Standards / Tailored Process]
Cybersecurity [Common Criteria ISO/IEC 15408, ISO/IEC 27001, NIST 800]
Software Risk Assessment - Design FMEA [BS/EN/ISO 14971, IEC 60601-1]
21 CFR Part 11 Implementation.