What sets us apart?


Whether you need to improve your computer validation approach, select a new computer or control system, upgrade an existing system, or make your system part 11 compliant, CQI can help. We specialize in providing practical and cost-effective solutions which make your systems work better while maintaining and improving FDA compliance.


Our experienced in the GMP regulated industries team will help you to validate your Facility, Utility Systems and Equipment.

We offer to the following services:


Computerized Systems

  • Software Design
  • Software Validation
  • Compliance Assessment and Planning
  • System Integration
  • Data Migration
  • Specifications
  • Vendor Audit
  • CFR 21, Part 11 ER/ES:
    • Assessment
    • Remediation

Validation Planning and Management

  • Policy Development
  • Validation Master Plan
  • Project Management
  • Protocols Preparation
  • Qualifications Execution

Utility Systems and Equipment Validation

  • Sterilizer
  • Depyrogenation Ovens
  • Cold Rooms
  • Cryo-Storages
  • Liophilizers
  • Centrifuge
  • Environmental Chambers
  • Incubators
  • Fermentors
  • Tanks

Calibration Program Management

  • Metrology Policy
  • Recalibration Procedure
  • Scheduling Software
  • Calibration SOPs
If you would like more information about our services, rates or references, please contact us using our Contact page.