Our approach to providing validation services is adaptable to each client's needs and company procedures, and is applicable to any computer system validation project. We can provide your organization with the following services:
  • Validation Project Management

  • Document Templates for Validation Deliverables

  • Preparation of Validation Plans and/or Protocols

  • User Requirements Specification Development

  • Validation Test Script & Test Data Creation

  • Test Script Execution & Analysis of Results

  • Traceability Analysis & Traceability Matrix Preparation

  • Preparation of Validation Summary Reports

  • Evaluation/Assessment of Validation Documents

  • Evaluation and/or Development of SOPs

  • Risk Management Activities & Documentation Preparation

  • Part 11 Gap Analysis & Remediation Plan Development

  • User Acceptance Test execution Support

  • Vendor Audits of Technology Providers

For additional information on our consulting & auditing services, contact FDAQRC at 1.866.400.8996 x700.