IT/OT Infrastructure Implementation & Qualification
Your IT/OT infrastructure is the backbone of every validated system, driving compliance, performance, and scalability in regulated life sciences environments.
Whether you’re building new infrastructure or evolving an existing system, Valspec delivers end-to-end implementation and qualification across on-prem, cloud, and hybrid environments.
Our Expertise
Where Implementation Meets Validation
Most firms get systems running. We make sure they perform and pass.
Rooted in Computerized Systems Validation (CSV), we deliver Risk-Based Qualification with audit-ready documentation—led by specialists who understand complex, regulated environments and anticipate what’s next.
Risk-Based Validation
Testing aligned to system criticality—never over- or under-engineered
Leverage-First Mindset
Incorporating vendor and third-party testing to reduce redundancy and cost
Gap-Focused Execution
Identifying what’s missing and validating only where needed
End-to-End Lifecycle Expertise
From early design through final QA handoff
What We Do
Our Capabilities
We configure and qualify infrastructure across a wide range of technologies used in regulated life sciences operations:
•Physical machines and on-premise infrastructure
• Local host servers and virtualized environments
• Cloud-based and hybrid architectures (AWS, Azure, etc.)
• Network-connected systems (PAT instruments, edge devices,
UNS nodes)
• Controllers, PLCs, distributed control systems, and field devices
• Servers, applications, data systems, and enterprise connectivity
across IT and OT layers
Our team works across platforms and vendors to ensure seamless integration, alignment, and long-term system performance.
Our Approach
How We Deliver with Confidence and Control
Every infrastructure project comes with complexity—multiple stakeholders, evolving requirements, and no room for error. We bring the structure needed to keep everything aligned and moving.
Plan with Intent
We engage early to understand your system goals, stakeholder priorities, and architectural drivers, aligning teams and setting a clear path forward from the start.
Validate with Precision
We perform risk assessments to define the right validation strategy, then build a test matrix that ensures efficient, targeted execution across environments.
Execute with Control
We execute against plan while adapting to real-world conditions, delivering a complete, audit-ready SDLC and qualification package aligned with QA expectations.
Real-World Results
Proven in Complex, High-Stakes Environments
Valspec delivers infrastructure implementation and qualification in environments where precision, coordination, and compliance are critical, without disrupting ongoing operations.
Greenfield Facility: Genentech Clinical Supply Center
South San Francisco, CA
As part of a new facility build, Valspec led the qualification of a fully integrated digital and automation ecosystem supporting clinical supply operations.
Scope & Systems:
• Siemens Desigo BAS
• Emerson DeltaV DCS (with PLC integrations)
• Emerson Syncade MES
• Aveva PI Data Historian
• Process Analytical Technology (PAT) instruments
Project Complexity:
• Greenfield facility requiring full system qualification from the ground up
• Multiple integrated systems across IT and OT layers
• Alignment across vendors, systems, and validation requirements
Impact:
• Fully validated infrastructure delivered for operational readiness
• Strong foundation for compliant, scalable clinical supply operations
Brownfield Facility: Genentech PIT Project
Oceanside, CA
In a live production environment, Valspec led a complex infrastructure transformation that required precision execution and uninterrupted operations.
Scope & Systems:
• Split a single DCS into upstream and downstream systems
• Commissioned and qualified 10 DCS environments
(PROD, VAL, DEV)
• Integrated 2,000+ new I/O points
• Implemented new controllers and communication pathways
Project Complexity:
• No dedicated shutdown window—production remained active
• ~80% of control infrastructure modified
• High coordination and traceability requirements across teams
• “Open-heart” system changes within a live facility
Impact:
• Zero downtime to production
• Accelerated delivery through strategic test leveraging
• Flexible execution aligned with construction and production schedules
Helpful Insights
Frequently Asked Questions
Don’t wait
Let’s Talk About What You’re Building
Whether you’re planning your next digital system project, navigating infrastructure changes, or need support across the validation lifecycle, we’re here to help.