IT & OT Infrastructure Qualification
We qualify the base your GxP systems run on — without retesting every application.
Infrastructure qualification ensures the technology base GxP systems run on — servers, networks, virtualization, cloud and industrial automation — is reliable, secure and compliant, on a "qualify once, deploy many" model.
Infrastructure usually falls under GAMP category 1: we speak of qualification, not validation. Standard components are qualified once and reused across many deployments.
We cover IT (Information Technology) and OT (Operational Technology): industrial control systems (ICS), SCADA and PLCs, with attention to cybersecurity, access control and data integrity.
Deliverables cycle
Infrastructure Technical Specification
Components, topology and IT/OT requirements — on-premises or cloud — defining the base to be qualified.
Installation Qualification (IQ)
Verification of servers, network, virtualization and connectivity against the approved technical specification.
Access Control & Cybersecurity
User management, hardening and risk mitigation, ensuring a secure environment with data integrity.
Redundancy & Failover
Testing the mechanisms that keep critical processes running through failures.
Periodic Review
Requalification and maintenance of the controlled state over time.
How we run it
Map infrastructure
IT/OT inventory and definition of qualifiable scope.
Specify & assess risk
Technical specification and vulnerability analysis.
Qualify
IQ, access control, redundancy and failover.
Keep controlled
Change control and periodic review.
Applicable standards
Frequently asked questions
Qualification or validation?
Infrastructure (GAMP category 1) is qualified; applications are validated. We handle both in an integrated way.
Is cloud in scope?
Yes. Cloud and hybrid environments are qualified with a focus on shared responsibility and cybersecurity.
What about Operational Technology (OT)?
We qualify ICS, SCADA and PLCs, following good automation and industrial security practices.