IQ / OQ / PQ + annual verification.
IQ/OQ/PQ at install plus annual re-verification — signed documentation your QMS, CLIA/CAP inspector, or sponsor audit requires.
Three-stage instrument qualification.
Each stage is signed-off in writing and added to your instrument file. Protocols cover the Qsep1, Qsep1-Plus, Qsep100, Qsep100 2.0, Qsep100 2.0 Advance, and Qsep400.
IQInstallation Qualification
The Qsep arrives, gets unboxed, sited, and powered up under our on-site engineer. We verify the serial number, accessories pack-out against the BOM, environmental conditions, network / LIMS connectivity, and Q-Analyzer software install. You receive a signed IQ protocol with all checks evidenced.
OQOperational Qualification
Voltage stability, capillary auto-fill, LED-induced fluorescence calibration, cartridge handshake, and pressure tests all run through a documented OQ protocol. Pass/fail thresholds are set against BiOptic factory specs — same checkpoints used for the instrument's own QC release.
PQPerformance Qualification
End-to-end run on a known sample (size standard or a customer-supplied control) through the cartridges your lab will actually use. We verify sizing accuracy (±2 bp on the S1 high-resolution cartridge), peak resolution, and reproducibility across replicate injections. PQ report ships with the instrument file.
Annual performance verification.
Once a year, on a date you set, we re-run a focused subset of OQ + PQ checks against the same factory thresholds — and re-issue a dated certificate of performance. Audit-ready, no scramble.
Scheduled, not reactive
We hold the calendar so the verification window doesn't drift past your QMS deadline.
Re-issued certificate
Dated, signed, and traceable to the BiOptic factory thresholds — slot it straight into your audit binder.
Same checks, same thresholds
Voltage stability, cartridge handshake, sizing accuracy, peak resolution. Same protocol you signed off at install.
Bundled with extended warranty
Annual verification can roll into a 1 / 2 / 3-year extended warranty on Qsep1, Qsep100, or Qsep400.