We run the calibration program so your QA team doesn't have to. Strategy, consulting, vendor oversight, asset list remediation, and audit support — one accountable partner across every instrument in your facility.
Pick the parts you need or hand us the whole program. Either way, you get a single accountable partner instead of a stack of disconnected vendors.
End-to-end ownership of your calibration program. We define the strategy, build and maintain the schedule, manage the work, and own the documentation lifecycle — so calibration stops being a fire drill and becomes a predictable, audit-ready function.
Targeted engagements when you don't need a full program partner but do need an expert in the room. SOP authoring and review, tolerance-setting policy, calibration interval strategy, and pre-inspection readiness.
Bring in a layer of accountability across every outside calibration provider you use. We qualify them, monitor their certificates, and own the relationship so you don't have to chase paperwork or argue tolerances vendor-by-vendor.
Inherited a messy program? Stale asset lists, missing tags, orphaned instruments, drifted intervals, conflicting tolerances? We do the unglamorous foundational work to get the program back on solid ground — one asset at a time.
An honest, outside read on where your calibration program actually stands — against FDA expectations, ISO 9001, and the realities of a modern pharma inspection. Findings come with prioritization and a remediation roadmap, not just a list of problems.
If your QA team is spending more time chasing calibration paperwork than improving quality, the program is running them — not the other way around.
Most program-management engagements follow the same four-stage path. Step one is always discovery — we don't quote a long-term commitment until we know what we're inheriting.
Two to three days on site reviewing the existing program, walking the floor, interviewing QA stakeholders, and pulling a representative sample of records. Output: a written gap analysis with risk-ranked findings.
Findings translate into a remediation roadmap with effort estimates. You choose which pillars to engage on — full program, vendor control only, asset remediation, audit support, or any combination.
Master asset list rebuilt, tolerances rationalized, schedule reset, SOPs revised. Vendors qualified or re-qualified. By end of this stage, the program has a clean foundation to operate against.
Quarterly program-health reports. Continuous schedule maintenance. OOT investigations triaged in real time. Annual re-audit confirms the program continues to meet inspection-ready standards.
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