TechkratesCSV/CSA Criticality and Risk Review
A criticality map and the validation approach for one system. Result in 3 working days, from CHF 950.
Risk mapCSV/CSA approachEvidence path
CSV and CSA for software and connected systems
Risk-based validation for systems that support product development and regulated manufacturing: intended use, data integrity and audit-ready evidence, without document overhead.
- GAMP 5
- FDA CSA
- 21 CFR Part 11
- EU GMP Annex 11
- IEC 62304
Typical tasks
From a three-day review to a validated system.
Validation of one computerised system
Plan, intended use, risk assessment, test scripts and report, sized to the system's real risk.
Validation planTest scriptsReport
Traceability and change rules for a connected system
Hardware, firmware, cloud and apps in one matrix, with rules for what a change must re-validate.
Trace matrixChange rules
From CSV to CSA
Formal protocols where the risk is high, streamlined checks with a rationale where it is low.
CSA roadmapRationale
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
CSV to CSA for a connected device add-on with cloud services, US-bound: audit-ready evidence across hardware and software, and faster iteration cycles.
A project led by our founder. The full case is on the projects page.
Standards we work with
- GAMP 5
- Risk-based approach to computerised systems
- FDA CSA
- Computer software assurance guidance
- 21 CFR Part 11
- Electronic records and signatures
- EU GMP Annex 11
- Computerised systems
- IEC 62304
- Where software life cycle evidence is needed
- ISO 13485
- Document control, with ISO 14971 risk management
CSV defines what must be validated. CSA focuses the evidence on risk, so low-risk functions do not carry the paperwork of high-risk ones.
FAQ
Questions we hear first.
How long does it take?
The assessment and plan take one to two weeks. Execution is phased with your releases.
Do you cover vendor systems such as MES, LIMS or labeling?
Yes. The validation boundary follows intended use, data integrity and interfaces; vendor documents are mapped to your evidence needs.
How are changes handled?
Each change gets an impact assessment, and re-validation is sized to the criticality of what changed.
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