Equipment Qualification
Full qualification lifecycle for laboratory and production equipment, from design review to performance qualification.
What equipment qualification means with QCS
Equipment qualification establishes documented evidence that an instrument is installed correctly, operates as intended and performs consistently in your environment.
We execute Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), including Design Qualification (DQ) where the equipment is being specified from scratch.
DQ · IQ · OQ · PQWhat is covered
Each engagement is scoped in writing before any engineer arrives on site.
Design Qualification (DQ)
User requirement specifications, vendor assessment and design review before purchase commitments are made.
Installation Qualification (IQ)
Verification of delivery, utilities, environment, documentation, software version and installation against specification.
Operational Qualification (OQ)
Functional testing across the operating range, alarms, interlocks, security and audit-trail checks.
Performance Qualification (PQ)
Routine-condition performance testing with real or simulated loads, repeated to demonstrate consistency.
Requalification
Periodic requalification after relocation, major repair or at defined intervals in your quality system.
The paperwork is the product.
An engagement is not finished when the engineer leaves — it is finished when your quality unit has the records in hand.
- Qualification protocols and executed reports
- Instrument-specific test scripts and acceptance criteria
- Traceable calibration certificates for all test instruments
- Requalification schedule
Equipment Qualification — common questions
Qualification (DQ, IQ, OQ, PQ) demonstrates that a piece of equipment is correctly specified, installed, operating and performing. Validation demonstrates that a process, cleaning procedure or analytical method consistently produces results meeting predetermined criteria. Equipment qualification is normally a prerequisite for process validation.
Either. We can author protocols and reports for your approval, or execute and document against protocols your quality unit has already approved.
A single instrument IQ/OQ/PQ is usually completed in one to three days on site. A full laboratory or facility program is scheduled by phase after a gap analysis, and typically runs over several weeks.
Often scoped together
Equipment Calibration
Certify your instruments against NIST-traceable master standards to establish data integrity across your laboratory and process floor.
Process Validation
Process, cleaning and method validation executed with calibrated master instruments and documented to regulatory expectation.
Repair & Maintenance
In-house maintenance laboratory and field engineers for repair, preventive maintenance and full backup support of laboratory equipment.