Qualification strategy
Define what must be qualified, to what depth, and how qualification will be maintained as the environment changes underneath it.
Infrastructure & cloud qualification
A validated system needs qualified ground to stand on.
Infrastructure used to be a room you could walk into. It is now a set of services that change weekly, operated by people you will never meet, under a contract you did not write.
Perspective
Qualification has to change with it. A one-off installation qualification against a static server estate proves very little about a platform that is patched continuously, scaled automatically, and reconfigured through code. The goal is a demonstrable, maintained state of control over the environment that regulated systems depend on — and clarity about which parts of it are genuinely yours.
Capabilities
Specialist support, connected to the whole system.
Scope is tailored to the engagement; these are the core areas in which QA4Tech can contribute.
Shared responsibility mapping
Establish precisely which controls the provider operates, which are yours, and which sit in the gap both sides assume is covered.
Cloud service qualification
Qualify IaaS, PaaS, and managed services using provider evidence where it is credible and independent verification where it is not.
Environment & configuration control
Bring environments, baselines, infrastructure-as-code, and configuration drift under a change regime that holds.
Continuous qualification
Design qualification that absorbs patching, releases, and automated deployment without a project every time.
Resilience & continuity
Assess backup, restore, disaster recovery, and continuity against what the regulated process can actually tolerate — tested, not assumed.
Shared responsibility
The layers, and who is answerable for each.
Almost every serious cloud finding traces back to a layer where both parties believed the other was in control. Mapping the stack explicitly is the first deliverable, not a preliminary.
Facility & physical
Data centre, physical access, power, and environmental control. Provider-operated, evidenced through certification and attestation reports rather than inspection.
Network & connectivity
Segmentation, routing, encryption in transit, and the perimeter between provider and tenant. Usually shared, and rarely documented as such.
Compute & storage
Instances, containers, storage services, backup, and encryption at rest. The boundary moves with the service model, which is where confusion starts.
Operating platform
Operating systems, runtimes, databases, and middleware. Yours under IaaS, the provider’s under PaaS, and the distinction has real consequences.
Identity & access
Directory, authentication, privileged access, and segregation of duties. Almost always the customer’s responsibility, and almost always the weakest evidence.
Application & data
The regulated system, its configuration, and its data. Unambiguously yours in every service model, including SaaS.
Continuous change
Qualification that survives a weekly release cycle.
A qualified environment that cannot absorb change becomes an unqualified one within a quarter. These are the controls that keep the state current instead of nominal.
- Risk-based assessment of provider change notifications, including changes made without notice
- Patch and update management with defined criticality, testing, and record expectations
- Infrastructure as code, versioned baselines, and drift detection with a defined response
- Deployment pipeline controls: approvals, segregation of duties, and traceable release evidence
- Monitoring, logging, alerting, and log retention proportionate to regulatory need
- Periodic review of the environment, its controls, and their continued effectiveness
- Backup, restore, and disaster recovery testing evidenced against a stated recovery objective
Approach
Context first. Evidence throughout.
A clear sequence keeps the work rigorous while avoiding unnecessary process.
- 01
Scope the estate
Identify which environments, services, and dependencies genuinely support regulated activity — including the ones nobody listed.
- 02
Split the responsibility
Map the stack against the contract and the provider’s own documentation, and surface the gaps in writing.
- 03
Qualify proportionately
Use provider certification and attestation where it holds, and verify independently where the regulated risk requires it.
- 04
Keep it qualified
Establish the change, monitoring, and periodic review controls that maintain the state rather than re-establishing it annually.
Deliverables
What the engagement produces.
A qualification approach that fits how the environment is actually operated, with the evidence to support it.
- Infrastructure qualification strategy and scope definition
- A documented shared-responsibility matrix per service and provider
- Qualification protocols and evidence proportionate to the layer and its risk
- An assessment of provider certifications and attestation reports, with residual gaps named
- Change, configuration, and environment control procedures
- A continuous qualification and periodic review model with defined triggers
Reference frameworks
The expectations applied to the environment.
Infrastructure qualification borrows from both regulated-industry guidance and mainstream IT service management, because the environment is run to the latter.
- GAMP 5 & the ISPE IT infrastructure guidance
- Risk-based qualification of infrastructure and platform services within a regulated computerized system lifecycle.
- EU Annex 11
- Expectations for the IT infrastructure supporting computerized systems, including suppliers and service providers.
- ISO/IEC 27001
- Information security controls used as provider evidence, with certificate scope examined rather than accepted.
- SOC 2 & similar attestations
- Read for what they actually cover: period, scope, exceptions, and the complementary controls left to you.
- ISO 22301 & recovery objectives
- Continuity and recovery capability assessed against what the regulated process can tolerate.
These are examples, not a complete list. The frameworks and criteria that apply to a particular engagement are identified and agreed as part of defining its scope.
Typical applications
Where this work can apply.
- First qualification of a cloud environment for regulated use
- Migration from on-premises infrastructure to a hosted platform
- Qualification that has fallen behind continuous change
- Assessing provider attestation reports and residual responsibility
- DevOps and CI/CD pipelines supporting regulated systems
- Disaster recovery and continuity evidence for a critical system
Start a conversation
Bring the right level of assurance to the next decision.
Begin with a focused discussion about context, risk, evidence, and the outcome you need.