What We Offer

Xevalics is a forward moving company that embraces diversity, inclusion, and innovation. We provide strategic value-added solutions to your most complex challenges. Our team is committed to create value on every assignment through effective project management and transformation by enriching the relationship between people and technology.

Computer Systems Validation (CSV) / Computer Software Assurance (CSA)

  • Risk Assessments
  • Validation Master Plans Development
  • IQ/OQ/PQ Protocol Development and Execution
  • 21CFR Part 11 and Annex 11 Compliance
  • Computerized Systems Part 11 Gap Assessments
  • Systems Retirement and Decommissioning

Learn More »

Data Integrity

  • Data Integrity Program Development
  • Computerized Systems Data Integrity Assessments
  • Data Processing Maps

Learn More »

Program and Project Management

  • Project Charters
  • Project Plans
  • Project Schedules
  • Communications Plans
  • Prototypes and Model Office
  • Estimates
  • Status Reports
  • Project Summary Reports
  • Lessons Learned

Learn More »

Quality, Compliance & Regulatory Services

  • SOPs Development
  • Content Review/Approval Workflow Definition
  • Document Control and Document Management
  • Systems Implementation
  • GMP Change Management / Impact Assessments
  • CSV and IT Quality Assurance

Learn More »

Digital Transformation / Information Technology (IT)

  • IT Software / Infrastructure Corporate Policies and Procedures Development and Implementation
  • Users Requirements and Systems Requirements Definition
  • Systems Design
  • Logical and Physical Security Controls Design and Implementation
  • Tests Plan and Test Strategy Designs

Learn More »

Cloud Computing and Cybersecurity

  • Cloud Based Solution Service Level Agreements
  • Cloud Based Services Risk Assessments
  • Cloud Based Services Validation
  • Software Bill of Materials (SBOM) Generation & Maintenance
  • Threat Models & Assets Vulnerability Lists
  • Security & Privacy Verification Test Plans
  • Premarket Submissions Security Architecture
  • Cybersecurity Testing

Learn More »

Risk Management

  • FMEAs Development and Implementation
  • Planning and Pre-Work
  • FMEA Team Meetings
  • RPNs Evaluation
  • Action Plans Definition and Tracking
  • Follow-Up and Reassessments

Learn More »

Let’s Connect

Get to know the Xevalics team today. We promote inclusivity, diversity, and equity. Call today for quality, project management, and risk management consulting services.