TechkratesQualification Gap Check
A review of URS, specifications and vendor documents. Result in 3 working days, from CHF 750.
Gap listQualification pathNext steps
Equipment qualification: DQ, IQ, OQ, PQ, FAT and SAT
Release production equipment faster with lean, risk-based qualification. Protocols, execution and reports that QA signs the first time, on site or remote.
- DQ/IQ/OQ/PQ
- FAT/SAT
- CSV/CSA
- GAMP 5
- ISO 13485
- 21 CFR Part 11
Typical tasks
From a three-day gap check to the released machine.
DQ to PQ of one machine, with FAT and SAT
Plan, protocols, execution and reports, risk-based and in your templates.
PlanProtocolsReportsDeviations
FAT/SAT Acceptance Pack
Acceptance criteria and a punch list aligned to your URS. One week, from CHF 1 500.
CriteriaChecklistPunch list
CSV or CSA for a computerised system
From the risk assessment to the report, sized to the system's real risk.
Risk assessmentTest scriptsReport
Machinery safety and CE, in the same project
For test stands, fixtures and small machines you build in-house: risk assessment to ISO 12100, safety functions to ISO 13849-1, electrical equipment to IEC 60204-1, the technical file and the declaration, qualified in the same project.
Industrialization and production equipment →How we start
From the first call to the documents, in four steps.
Work starts within a week of the offer.
- 30 minutes
Scope call
The device, the task, the deadline and your quality system.
Call notes - Within 2 days
Fixed offer
Deliverables, price and dates on one page.
Offer · plan - Start within a week
Work
Design, build and test, with a short status every week.
Weekly status · reviews - At the end
Handover
Everything in your templates, ready for your DHF and your production.
Drawings · reports · files
Proof
Two new cleanroom production machines qualified from DQ to PQ within two months, FAT and SAT written and run, PQ with stability testing.
From our founder's track record, for a Swiss medical device manufacturer.
Standards we work with
- ISO 13485
- Validation of production processes
- GAMP 5
- Computerised systems, CSV and CSA
- FDA 21 CFR 820
- QMSR, process validation
- 21 CFR Part 11
- Electronic records and signatures
- ISO 14971
- Risk-based depth of testing
Three ways to work: documentation only, co-execution with your team, or full execution on site.
FAQ
Questions we hear first.
Can you work only on the documents?
Yes. We write the plan and protocols and your team executes, or we execute with you, or we run it on site.
What happens after a change to the machine?
We assess the change impact and requalify only what the change touches, with a written rationale.
Do you do CSV and CSA?
Yes, for production and lab systems, risk-based to GAMP 5 and the FDA CSA guidance.
Do you sign an NDA, and who owns the results?
Yes. Techkrates signs your NDA before the first technical details, and the designs, documents and data made for your project belong to you.
In which language are the documents?
German or English, in your templates and your document numbering.
Send two or three lines about the device and what you need.
An engineer answers within 24 hours. At a fixed price per task or from CHF 950 per day.
- Company
- Techkrates, Zurich
- On site
- Switzerland and Germany
- Languages
- English, German
- Contact