Equipment Qualification (DQ/IQ/OQ/PQ) + FAT/SAT for Swiss MedTech Manufacturing
Release production equipment faster with lean, audit-ready qualification that aligns DQ/IQ/OQ/PQ and FAT/SAT to real risk. We keep the scope tight, the evidence clear, and the handover QA-ready. Based in Zurich, available on-site or remote across Switzerland.
If late requirements, cybersecurity, or testability are inflating scope, see verification-driven engineering in MedTech.
Talk to us: filip@techkrates.com • +41 783 20 66 33
Reference project
Two new cleanroom production machines, qualified in two months
- Qualification plan and DQ/IQ/OQ/PQ protocols
- FAT/SAT and cleanroom execution support
- Part corrections during qualification, tests across all product combinations
- PQ with stability testing
Outcome: both machines qualified within two months, with a clean QA evidence package.
Start small
Qualification Gap Check (result within 3 working days)
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)
Engineering delivery modes
- Documentation-only (your team executes)
- Co-execution (we execute with your team)
- Execution & stabilization sprint (on-site/remote)
Scope and evidence expectations agreed upfront; changes handled via clear change requests.
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
FAT vs SAT vs IQ/OQ – how they fit together
FAT proves the supplier build meets the URS before shipment. SAT confirms the same criteria after installation and utilities hook-up. IQ locks the installed baseline (as-built, utilities, calibration), while OQ challenges the operating window with controlled tests. PQ, when required, verifies performance under routine process conditions. Together they create a traceable release path.
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
Machinery safety and CE for in-house built equipment
For test stands, fixtures and small production machines that MedTech manufacturers build themselves. One machine, two document sets: the CE documentation and the qualification are prepared together, from the same requirements and the same tests.
- Risk assessment to ISO 12100
- Safety functions and safeguards to ISO 13849-1: light curtains, interlocks, emergency stops
- Electrical equipment to IEC 60204-1
- Technical file and declaration of conformity
- DQ/IQ/OQ/PQ of the same machine
Not included: performance level calculations, SISTEMA validation and safety PLC programming.
Related insights
- Process validation for MedTech suppliers: DQ, IQ, OQ and PQ in practice
- IQ vs OQ in practice: What evidence counts (and what does not)
- Qualification documentation gaps that delay equipment release
- FAT vs SAT: Acceptance criteria that prevent surprises
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.
What if the equipment includes software or data flows?
We align the qualification scope with CSV/CSA expectations so software, PLC/HMI versions, and data integrity controls are covered without over-testing.