Independent validation for laboratories and the manufacturers who serve them.
Placed is notproducing.
APCP Solutions validates, implements, and activates diagnostic instruments so the laboratory's menu goes live and the installed base starts producing from day one.
The gap
An idle instrument fails twice.
The manufacturer sells the instrument and installs it. Validation belongs to the laboratory, and the laboratory is short-staffed, so the instrument sits. Every month it sits, the laboratory keeps paying for send-outs it meant to bring in-house, and the manufacturer waits for reagent pull-through that never arrives. Nobody is winning while it sits.
0to 12 months
Published estimate for a laboratory to run and approve a single assay validation on its own, with no revenue from the assay until it is done
0%
Core laboratory staff positions sitting unfilled, the highest vacancy of any department surveyed. Placed instruments land where staffing is thinnest.
Sources: assay validation timelines as published in US Patent 9,143,581; core laboratory vacancy rate, ASCP 2022 Vacancy Survey, American Journal of Clinical Pathology.
Services
Everything between placed and producing.
We plan and execute validation on site for new placements. Method verification, statistical analysis, and sign-off ready documentation, contracted directly by the laboratory so the instrument goes live on a defined timeline.
Independence
Independent by design.
We work for the laboratory. The result works for everyone. Validation performed by an independent third party protects the laboratory, the manufacturer, and the patient behind the result. APCP Solutions is not owned by or exclusive to any manufacturer.
- The laboratory hires us. Every engagement is contracted and paid by the laboratory at fair market value.
- An introduction is only an introduction. Laboratories choose their validation partner freely, and using us is never a condition of any sale.
- Fees are fixed and set in advance, never a share of instrument or reagent sales.
- The laboratory director reviews and signs every validation. We prepare, the laboratory accepts.
- Findings from a site reach a manufacturer only with that laboratory's written consent.
The team
Over twenty years each. Not a training ground.
The industry norm is to staff implementations with early-career personnel who learn on the instruments they are sent to stand up. Every APCP principal is board certified and brings more than twenty years in laboratory medicine.