Verify installation environment, components, utilities, calibration, and safety
EQUIPMENT & PROCESS QUALIFICATION
IQ, OQ & PQ Qualification
We structure installation, operating-range, and performance evidence with deviation and retest criteria.
RECOMMENDED FOROperations teams that need documented fitness and repeatable performance before using equipment, systems, or processes
Laboratory image: CDC PHIL, public domain
SCOPE OF WORK
Scope of work
Before contracting, we confirm the current state and responsibility boundary, then fix only the necessary work in scope.
Test operating ranges, alarms, interlocks, and worst-case conditions
Confirm performance using actual materials, operators, and lot conditions
Control deviations, retests, conditional acceptance, and approvals
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
Check criteria and state
Compare URS, risks, vendor documentation, and the installed state.
- 02
IQ
Verify installation, configuration, required records, calibration, and safety.
- 03
OQ
Verify operating ranges, controls, alarms, and worst-case behavior.
- 04
PQ
Confirm repeatability and performance under actual use conditions.
RESPONSIBILITY BOUNDARY
Conditions and responsibility boundary
IQ, OQ, and PQ are not document packages alone. Completion requires the actual state, raw data, review, and approval records.