Confirm lot purpose, quantity, materials, schedule, and disposition criteria
RUO & ENGINEERING PILOT
RUO & Engineering Pilot Lots
We produce engineering and research-use lots while linking process conditions, inspection results, and lot history.
RECOMMENDED FORProduct teams that need real-lot evidence for process conditions and inspection criteria before commercial manufacturing
SCOPE OF WORK
Scope of work
Before contracting, we confirm the current state and responsibility boundary, then fix only the necessary work in scope.
Control work sequence, in-process inspection, raw data, and finished-product identification
Record process conditions, operators, equipment, and deviations by lot
Review inspection results and determine release or research-use status
KEY DELIVERABLES
Evidence that remains
We prioritize the connection between requirements, execution, results, and approval over document names.
WORKFLOW
Workflow
We review each stage before moving forward and retain unresolved items in a controlled action register.
- 01
Fix the scope
Define the research purpose, performance questions, and lot completion criteria.
- 02
Prepare materials and equipment
Release only identified, calibrated, and status-verified items for execution.
- 03
Execute the lot
Follow the approved sequence while recording in-process checks and deviations.
- 04
Review and disposition
Determine lot status from raw data, process records, and inspection evidence.
RESPONSIBILITY BOUNDARY
Conditions and responsibility boundary
Our currently published scope covers RUO and engineering pilot work. Commercial IVD manufacturing is contracted separately after facilities, licenses, and GMP scope are confirmed.