Validation Services

Full portfolio of validation services implemented as individual activities or turn-key services

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

Business Process Consulting

Technology Support Services

Services tailored to meet the needs for big or small, well defined or development needs

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