Systems Strategy & Governance
Decision rights, recipe lifecycle, change execution, and release strategy that scale.
Learn more →Wa-Vi Solutions
Operational clarity for regulated manufacturing
Wa-Vi Solutions helps biotech and pharma manufacturing sites design, govern, and operate computerized systems and production operations—reliably, audit-ready, and built to scale.
Systems governance
Manufacturing operations
Change readiness
Audit-ready delivery
Operational insights
Enterprise professional. Pragmatic. Outcomes-focused. No hype.
Regulatory-literate, practical
GxP-aware delivery with risk-based thinking—without document overload.
Designed for operations
Uptime, change execution, readiness, and sustainment—built into the operating model.
Cross-functional by default
Aligned execution across Manufacturing, QA, MSAT, IT/OT, Automation, and Validation.
Services
Engagements are tailored to your site maturity, risk profile, and timeline.
Manufacturing Operations & Reliability
Incident/problem patterns, monitoring strategy, sustainment and reliability improvements.
Learn more →GxP Compliance Enablement
Risk-based documentation, audit readiness support, and data integrity mindset.
Learn more →Implementations & Change Readiness
Readiness → cutover → hypercare planning, coordination, and stabilization models.
Learn more →Reporting & Operational Insights
KPI definition and dashboard requirements for actionable operational visibility.
Learn more →Network of Consultants
Bring specialized support when needed: Automation, CSV/CSA, Validation, OT, Cybersecurity, Quality Systems.
How the network works →Not sure where to start?
A short discovery call can clarify fit and next steps.
Common use cases
Generic, anonymized examples of where Wa-Vi is typically brought in.
Scale-up readiness
Clinical → commercial transition requiring stronger governance, controlled change execution, and reliable operations.
System stabilization post go-live
Reduce recurring incidents, clarify ownership, strengthen support, and improve release readiness.
Systems implementation planning
Readiness assessment, cutover planning, and hypercare model built to minimize production disruption.
Audit readiness enablement
Risk-based documentation patterns and inspection narratives across QA, IT, and Manufacturing.
How we work
Three engagement models depending on urgency, complexity, and execution needs.
Advisory Sprint
2–6 weeks to assess, align stakeholders, and produce a clear roadmap and decision set.
Details →Embedded Support
Hands-on leadership within your team during critical phases and cross-functional delivery.
Details →Change Readiness + Hypercare
End-to-end readiness, cutover planning, and stabilization through high-risk transitions.
Details →Trust markers
Senior regulated manufacturing leadership with deep focus on operational execution.
No vendor bias
Platform-agnostic support, delivered with independent, site-first decision-making.
Pragmatic compliance
Risk-based documentation and inspection readiness—without claiming “guaranteed compliance.”
Let’s talk about your site’s reality—not a slide deck.
Share what’s happening and we’ll propose a practical next step.