Computer System Validation (CSV) for MedTech Manufacturing

CSV (Computer System Validation) for regulated MedTech manufacturing systems in Switzerland, with a defensible scope and audit-ready evidence.

CSV matters wherever software or connected systems influence product quality, compliance, or data integrity — from equipment controllers and MES/LIMS to labeling, interfaces, and data flows across vendors.

CSA (Computer Software Assurance) does not replace CSV; it refines how evidence is produced by focusing effort on higher-risk workflows while keeping lower-risk checks proportionate.

Talk to me: info@techkrates.com • +41 783 20 66 33

What I deliver

Validation scope aligned to intended use and system criticality
Intended use statements, system boundaries, and interface inventory
Traceability from requirements to risks and tests
Test strategy (CSV vs CSA) with risk-based coverage
Audit-ready evidence pack: protocols, reports, and review notes
Change impact assessment and re-validation triggers

Typical problems I fix

Unclear validation boundaries between equipment, software, and vendors
Vendor updates without a structured impact assessment
Small embedded or library changes triggering full re-validation
Late cybersecurity workstream colliding with CSV execution
Audit readiness gaps: missing traceability or outdated versions
Data integrity controls not linked to intended use
Test scripts focused on low-risk paths, missing critical workflows
Re-validation scope ballooning due to inconsistent change records

CSV vs CSA in practice

CSV defines what must be validated and what evidence is required for regulated workflows. CSA focuses that evidence on risk: high-risk functions still need formal protocols and documented results, while low-risk functions can rely on streamlined checks with a clear rationale.

Standards & expectations

Evidence aligns to ISO 13485 document control and ISO 14971 risk management. IEC 62304 applies when software lifecycle evidence is in scope. 21 CFR Part 11 and EU GMP Annex 11 are considered where electronic records or signatures are used.

Related insights

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FAQ

Do you cover vendor systems like MES, LIMS, or labeling platforms?

Yes — the scope is defined by intended use, data integrity impact, and interfaces. Vendor documentation is assessed and mapped to your evidence needs.

How do you handle vendor updates or patches?

Through a structured change impact assessment that defines what must be re-tested and what remains unchanged, with evidence aligned to criticality.

Is CSA accepted for MedTech manufacturing systems?

CSA is a risk-based way to focus evidence. We document the rationale so audit expectations are met in Swiss and EU contexts.

What do you need to start?

A brief system description, intended use, architecture or data flow overview, current versions, and any existing requirements and test evidence.