Services
CQV — Commissioning, Qualification & Validation
Full lifecycle qualification services — from protocol development through execution, review, and regulatory-ready documentation. Ensuring every system performs as intended, every time.
IQ
Installation Qualification
Verification that equipment is delivered, installed, and configured in accordance with the approved design specifications and manufacturer's recommendations.
OQ
Operational Qualification
Documented testing that equipment operates correctly throughout its specified operating ranges, including worst-case and boundary conditions.
PQ
Performance Qualification
Confirmation that equipment consistently performs as intended under actual or simulated production conditions, producing product that meets predetermined specifications.
Qualification Scope
- Clean Rooms — particle counts, air change rates, pressure differentials, recovery tests
- HVAC Systems — airflow verification, filter integrity, temperature mapping
- Water Systems — WFI loop qualification, sampling strategy, alert/action limits
- Autoclaves — heat distribution, heat penetration, BI challenges
- Filling Lines — media fills, dosing accuracy, CCI testing
- BMS / Control Systems — 21 CFR Part 11, alarm management, data integrity
Documentation & Compliance
- Qualification protocol writing and review
- Qualification report generation and approval
- Standard Operating Procedures (SOPs)
- Quality and engineering policies
- Maintenance instructions and schedules
- Calibration programs and laboratory setup