GxP infrastructure qualification for life sciences

Qualified, inspection-ready foundations for your GxP systems.

From on-premise data centres to private cloud, public cloud and SaaS platforms, regulators expect clear evidence that your IT infrastructure is qualified, controlled and fit for its intended use.

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Amalia helps life-sciences organisations design, qualify and maintain compliant IT infrastructure using pragmatic, risk-based methods grounded in GAMP IT Infrastructure Control and Compliance and EU GMP expectations.

Why GxP Infrastructure Qualification Matters

Regulatory frameworks make a clear distinction: applications are validated; infrastructure is qualified. EU GMP Annex 11 and Annex 15, together with 21 CFR Part 11 and related guidance, require that IT infrastructure supporting GxP systems is demonstrably fit for purpose and maintained in a controlled state.

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In practice, that means being able to show that servers, networks, databases, storage, virtual platforms and cloud services consistently support compliant operation of your validated systems.

Done well, it helps you:

With GxP Infrastructure Qualification

Risk reduction

‍Reduce risk to patient safety, product quality and data integrity

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Regulatory Compliance

‍Demonstrate compliance with EU GMP Annex 11/15, 21 CFR Part 11 and related GxP guidance

Audit Readiness

Improve audit readiness by making technical controls visible, justified and traceable

Validation Foundation‍

Provide a solid foundation for efficient CSV and CSA activities on top of that infrastructure

Without this foundation, even well-validated applications can be challenged by inspectors if the underlying platforms are not demonstrably under control.

What We Do Under Infrastructure Qualification

We provide end-to-end support for qualifying IT infrastructure across the full stack – from physical equipment to virtual platforms and hosted services – tailored to your risk profile and operating model.

Step 1

Infrastructure qualification strategy

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We develop a risk-based infrastructure qualification strategy that clarifies:

Which infrastructure layers are in scope

How components will be classified and qualified

How vendor evidence will be used

Roles, responsibilities and acceptance criteria

This ensures a clear, consistent and risk-based foundation for all subsequent qualification activities.

Step 2

Vendor and service-provider assessment

We support assessment of hosting and cloud providers, including review of:

Certifications and audit reports (for example ISO 27001, SOC reports)

Service descriptions and SLAs

Technical and security documentation

Shared-responsibility models and customer obligations

Findings are embedded into your overall qualification and supplier-management framework.

Step 3

Inventory and classification

infrastructure components that support GxP systems, including:

Servers and databases

Storage and backup platforms

Networks, firewalls and security layers

Virtualisation and container platforms

Cloud infrastructure and SaaS environments

Each component is assessed for GxP criticality so that effort is focused where it matters most.

Step 4

Specification and design review

review or create infrastructure requirements and design documentatioN:

Availability and resilience

Security and access control

Data integrity and segregation of duties

Backup, restore and disaster recovery

Performance, capacity and monitoring

This turns process maps into a practical backbone for roles, training, system design and compliance.

Step 5

Commissioning and qualification (IQ/OQ)

WE PLAN AND SUPPORT COMMISSIONING AND QUALIFICATION, FOCUSING ON:

Installation qualification (IQ) of infrastructure components

Risk-based operational qualification (OQ) where required

Leveraging vendor documentation, certificates and test evidence

Avoiding unnecessary duplication of testing activities

Proportionate, risk-based verification aligned with GxP expectations

This ensures that infrastructure is verified efficiently, using existing evidence where possible, while remaining compliant and demonstrably fit for purpose.

Step 6

Documentation and traceability

We create or optimise:

Risk assessments and qualification plans

Test protocols and reports

Configuration records and inventories

Traceability matrices linking infrastructure elements to supported GxP systems

This ensures a clear, end-to-end narrative from requirement and risk through to evidence.

Step 7

Change and lifecycle management

WE DEFINE AND REFINE LIFECYCLE PROCESSES, FOCUSING ON:

Controlled changes and impact assessment

Patching, upgrades and routine maintenance

Capacity and performance adjustments

Decommissioning and data retention

Proportionate, inspection-ready change documentation

This ensures that the qualified state is maintained over time through controlled, transparent and sustainable processes.

Step 8

Integration with CSV and CSA

WE ALIGN INFRASTRUCTURE AND APPLICATION ASSURANCE, FOCUSING ON:

Reuse of qualification evidence across CSV and CSA activities

Clear assumptions between infrastructure and application layers

Leveraging vendor evidence, performance data and monitoring insights

Minimising duplication of testing and documentation

Consistent, risk-based approach across validation layers

This ensures a streamlined validation approach where infrastructure and application assurance work together efficiently and coherently.

Deliverables

Typical deliverables from an Infrastructure Qualification engagement include:

Infrastructure qualification plan

Risk-based IQ strategy aligned with your quality system, CSV/CSA framework and regulatory expectations.

Inventory and classification

Documented list of GxP-relevant components with criticality ratings and ownership.

Requirements & specifications

Availability, security, data-integrity, backup and performance requirements, with supporting design documentation.

Risk assessments & TM

Linkage from requirements and risks through to qualification evidence and supported systems.

IQ/OQ protocols and reports

Commissioning and qualification documents, leveraging vendor evidence where appropriate.

Change and lifecycle procedures

Updated or new procedures for maintaining the qualified state through change, patching and decommissioning.

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All deliverables are aligned with GAMP IT Infrastructure Control and Compliance and your internal SOPs, so they stand up to both regulatory and customer audits.

Customer Stories & Insights

From Vision to Execution: Our Strategic Framework

The gap between a strategy document and functioning corporate governance is almost entirely about two design choices: how specific the values are, and how deeply the framework integrates with operational processes.

Inside the Quality Management System — We Built to Scale

A formally compliant QMS and a functional one are not the same thing. For a life sciences consultancy, the difference comes down to calibration — and the discipline to build something proportionate rather than just correct.

We will be adding more customer stories soon. Please check other categories till then

We will be adding upcoming webinars soon. Please check other categories till then

Outcomes You Can Expect

Clear, defensible GxP infrastructure status

Qualified platforms that stand up to regulatory and customer audits.

Better decisions and prioritisation

By separating infrastructure concerns from application validation and aligning evidence across CSV and CSA.

Lower operational risk and downtime

Through structured change control, configuration management and recovery planning.

Stronger compliance and control

Mandatory steps, approvals and records are built into process flows instead of bolted on afterwards.

When to Consider Portfolio Excellence

You are implementing or upgrading a GxP-relevant system on new infrastructure (on-premise or cloud)

You are bringing non-GxP systems into scope of GMP, GDP or other GxP regulations

You are migrating from one hosting provider to another, or consolidating environments

You are responding to infrastructure-related audit findings or inspection observations

You are introducing new platform technologies that will support validated systems

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Why Amalia

We help organisations turn complex change into solutions that people actually use. We combine structure, respect and creativity so your teams deliver better outcomes with less friction. Here is what that looks like in real engagements.

Simplicity by design — no unnecessary complexity

We remove what isn’t needed while keeping essential controls and compliance. The result is clear, practical systems that are easy to adopt and maintain.

One integrated team instead of new silos

A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.

Portfolio governance model

We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.

Process-first, risk-based delivery

Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.

Global experience, tailored to your context

We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.

It is personal for us

Senior leaders stay involved from start to finish on every engagement. Each programme is treated as a long-term partnership, not a one-off project.

Want to simplify complex work without losing control?

Work with a team that can join up governance, assurance, platforms and technical depth from start to finish.