Qualified to run. Documented to inspect.
We author and execute IQ/OQ/PQ protocols that prove your manufacturing equipment, process systems, and critical utilities perform as intended, the same way, every time. From sterile fill-finish to non-sterile solid dose, every qualification is engineered to withstand regulatory scrutiny.
IQ/OQ/PQ protocols for manufacturing equipment, process systems, and critical utilities, across sterile and non-sterile environments.
What we deliver, in depth.
Installation Qualification (IQ)
Verified installation against design specification, drawings, and manufacturer requirements, with full traceability.
Operational Qualification (OQ)
Challenge testing across the operating range to confirm equipment functions correctly under defined conditions.
Performance Qualification (PQ)
Sustained, reproducible performance under real production conditions and loads.
Critical Utilities
Qualification of water systems, clean steam, compressed gases, and HVAC across classified environments.
How we take it from scope to certified.
Assess
Define user requirements, system boundaries, and a risk-based qualification strategy.
Author
Draft protocols with pre-approved acceptance criteria and clear traceability.
Execute
Run qualification with senior oversight; document deviations transparently.
Certify
Compile inspection-ready summary reports and hand over a maintainable state.
Deliverables and the benefits behind them.
What you receive
- Validation Plans and qualification protocols (IQ / OQ / PQ)
- Requirement traceability matrices
- Executed protocols with reviewed raw data
- Deviation records and impact assessments
- Summary reports and qualification certificates
Why it matters
Sterile & non-sterile
One partner across both environments, so standards stay consistent across your network.
Risk-based scope
Effort concentrated where product and patient risk is highest, not spread thin.
Inspection-ready
Every protocol is written to hold up under FDA, EMA, and ICH scrutiny.
Related services.
Ready to scope your equipment & utility qualification work?
Contact us today for a complimentary scope discussion and project assessment with one of our founding consultants.