Equipment Qualification (DQ/IQ/OQ/PQ) + FAT/SAT for MedTech Manufacturing
Release production equipment faster with lean, audit-ready qualification that aligns DQ/IQ/OQ/PQ and FAT/SAT to real risk. I keep the scope tight, the evidence clear, and the handover QA-ready. Based in Zurich, available on-site or remote across Switzerland.
Talk to me: [email protected] • +41 783 20 66 33
Start small
Qualification Gap Check (2–4 hours)
Rapid review of URS/specs + available vendor docs; you get a prioritized gap list and a recommended path to DQ/IQ/OQ/PQ (scope by criticality).
- Prioritized gaps & missing evidence
- Recommended qualification path (DQ/IQ/OQ/PQ)
- Next-step plan (what to do first)
Who it’s for
- MedTech / Biotech manufacturing teams releasing new production equipment
- Cleanroom equipment, utilities, and critical process machines
- Test & assembly machines with regulated acceptance criteria
- Engineering + QA teams needing audit-ready evidence and traceability
- Supplier-built equipment requiring aligned FAT/SAT acceptance
Typical situations
- A new machine is arriving and the qualification plan is not defined
- FAT/SAT criteria are unclear or not aligned with QA expectations
- Equipment modifications trigger requalification needs
- Gaps exist in URS/requirements or acceptance criteria
- Deviations or evidence gaps delay release to production
Deliverables
- Qualification plan and risk-based scope definition
- DQ / IQ / OQ / PQ protocols and data sheets (as applicable)
- FAT/SAT acceptance criteria plus punch-list support
- Execution support, deviations log, and CAPA input as needed
- QA-ready reports and a traceable evidence package
- Verification test methods and GR&R/MSA evidence capture guidance
FAQ
How long does a qualification project take?
Most projects run 2–6 weeks per phase depending on equipment complexity, documentation maturity, and execution model. FAT/SAT timing can shorten the overall cycle.
Remote vs on-site — what do you recommend?
Planning and document work can be done remotely. Execution, FAT/SAT, and cleanroom activities typically require on-site presence.
How are scope changes handled?
Changes are managed through a clear change request with impact assessment, updated acceptance criteria, and agreement before execution.
What information do you need from us?
URS or requirements, drawings, calibration records, vendor manuals, software/firmware versions, and access to the equipment or FAT/SAT plan.