CSV & CSA for Product and Manufacturing Support Systems
Risk-based CSV/CSA for software and connected systems that support product development and regulated manufacturing. Focused on intended use, data integrity, and audit-ready evidence without document-heavy overhead. Ideal when change frequency and dependencies are high.
Talk to me: info@techkrates.com • +41 783 20 66 33
Start small
CSV/CSA Scope & Risk Review (4–8 hours)
Criticality map + validation approach for a system with data flows and dependencies; you get a clear testing/evidence path (CSV now, CSA where appropriate).
- Criticality / risk map
- Proposed validation approach (CSV/CSA)
- Test/evidence path for key workflows & data integrity
Who it’s for
- MedTech / Biotech product development and manufacturing teams
- Product and manufacturing support systems with data integrity needs
- Connected devices, cloud services, and data flow integrations
- QA/CSV leads who need a risk-based, defensible scope
- Teams transitioning from CSV to CSA approaches
Typical situations
- Complex systems with many dependencies across HW/SW
- Frequent changes driving repeated validation cycles
- US-bound / FDA context without clear evidence strategy
- Vendor software with gaps in documentation or intended use
- Unclear boundary between what to validate and what to assure
Deliverables
- Validation plan and intended use summary
- Risk assessment and scope definition by criticality
- Requirements-to-test traceability
- Test plans, scripts, and evidence capture packages
- Change impact assessment templates and re-validation guidance
- CSV to CSA transition roadmap where appropriate
FAQ
How long does CSV/CSA delivery take?
Timing depends on system complexity and documentation maturity. Initial scope and planning can be done in 1–2 weeks, with execution phased as needed.
Remote vs on-site — what do you recommend?
Most CSV/CSA work can be done remotely. On-site time is useful for system walkthroughs, key workflows, and audits.
How are changes handled?
Changes are assessed through structured change impact reviews, with re-validation steps scoped to criticality.
What information do you need from us?
System description, intended use, architecture or data flow overview, existing requirements and test evidence, and access to key stakeholders.