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System suitability tests (HPLC/GC)

In short

System Suitability Tests (SST) per USP <621> are the daily run-time checks — resolution, tailing, theoretical plates, RSD of replicate injections, signal-to-noise — that confirm the chromatographic system is fit before sample results are accepted. SST is the gate between the i...

System Suitability Tests (SST) per USP <621> are the daily run-time checks — resolution, tailing, theoretical plates, RSD of replicate injections, signal-to-noise — that confirm the chromatographic system is fit before sample results are accepted. SST is the gate between the instrument and the OOS investigation; without it a 'failure' cannot be defended as a real result and the data is unusable for release.

Regulatory anchors
  • USP <621>
  • ICH Q2(R2)
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
Reference standard qualification
Software that covers System suitability tests (HPLC/GC)
V5 Ultimate LIMS
V5 includes laboratory information management alongside production and quality: sample plans, requests, lab queues and results…
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