Computer System Validation Services

Quartica offers a range of validation support capabilities utilizing its onshore and off-shore resources. These services can be implemented either as individual activities or packaged turn-key model.

Quartica team members bring a wealth of expertise and hands-on validation and GxP experience. In addition to the life sciences domain expertise, the team also has experience working with industry best practices, standards and different methodologies. As there is no one particular methodology and best practice that suits all, the team is able to apply experience and identify the best approach aligned with customer processes, systems and methodologies to deliver results to our customers.

The table below depicts the select portfolio of validation support services applicable to this RFP:

Project Management and Delivery

  • Project Planning
  • Cost-Benefit Analysis
  • Change Management
  • Validation Strategy
  • Subject Matter Expertise

Technical Support

  • UAT Testing
  • Protocol Execution
  • Report generation
  • Documentation Support

Development and Support of Computer System Validation Deliverables

  • Validation Master Plan (VMP)
  • System risk assessment report
  • User requirements specification
  • System configuration specification
  • System Application Form (SAF)
  • Part 11 Gap Assessment Form (GAF)
  • System Assessment Checklist (SAC)
  • Effectiveness Check Form and Report (ECR)
  • Change Control Request for Remediation or Validation (CCR)
  • Validation Test plan
  • Validation Protocols - IQ, OQ, PQ
  • Requirements Traceability Matrix (RTM)
  • Quality assurance review
  • Validation summary report
  • Standard Operating Procedures (SOPs)
  • Others