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Instrument Qualification Services
IQ/OQ/PQ execution and documentation aligned to USP <1058>.
Qualification aligned to USP <1058>
Instrument qualification establishes documented evidence that a system is installed correctly, operates as intended and performs reliably for its intended use. For regulated laboratories it is the difference between data that survives an inspection and data that does not.
We execute IQ, OQ and PQ protocols configured to your site's SOPs and aligned to the USP <1058> analytical instrument qualification framework.
What we deliver
- Installation Qualification (IQ) — verified installation, configuration and environment against specification
- Operational Qualification (OQ) — module-level testing across the operating range your methods actually use
- Performance Qualification (PQ) — ongoing verification that the system performs to method requirements
- Requalification following repair, relocation or upgrade
- Audit-ready reports and certificates with full measurement traceability
Reducing review burden
A qualification package is only useful if QA can approve it. Reports are structured for review — clear pass/fail against stated acceptance criteria, traceability to the standards used, and deviations documented where they occur rather than buried in an appendix.
Talk to us about instrument qualification.
Send your instrument list and we'll come back with a scope and a quote — no obligation.