GxP audits for life sciences

Independent GxP audits across systems, processes, data and suppliers.

Regulators and customers expect you to know where you stand – not just on paper, but in day-to-day practice.

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Amalia provides independent GxP audits across your quality system, computerised systems, infrastructure, data lifecycle and suppliers. We review your controls against current expectations (GMP, GDP, GCP, GLP, GVP, 21 CFR Part 11, EU GMP Annex 11/15, GAMP, ICH Q7, Q9 and Q10) and translate findings into pragmatic corrective and preventive actions.

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We also audit SaaS, hosting and other third parties to confirm that your suppliers genuinely support your GxP obligations.

Why GxP Audits Matter

Good Practice (GxP) guidelines – GMP, GDP, GCP, GLP and GVP – sit alongside guidances like ICH Q7, Q9 and Q10, to define how life-sciences organisations must control quality, data and risk.

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At the same time, regulators have sharpened their focus on data integrity and ALCOA+ principles, treating weak data governance as a signal of deeper systemic issues.

Done well, it helps you:

With proper GxP Audits

Clear alignment between procedures and practice

‍SOPs, CAPA and quality processes are verified against real operations, ensuring they are both compliant and truly embedded in day-to-day activities.

Robust validation and infrastructure control

Ccomputerised systems and supporting platforms are consistently assessed and maintained in line with regulatory expectations.

Align processes with strategy and controls‍

Μodels link activities to goals, risks, controls and KPIs, so you can see whether processes support what the organisation is trying to achieve.

Transparent and controlled supplier oversight

‍SaaS providers, hosting partners and manufacturers are evaluated through structured audits, providing confidence in their ongoing compliance and performance.

Without structured GxP audits, compliance relies on assumptions and risks remain hidden. With them, you gain clear visibility and confidence in your quality and compliance posture.

What We Do Under GxP Audits

We tailor each GxP audit to your risk profile, combining what we audit with how we audit to give you a coherent, actionable picture.

Step 1

Quality-system and process audits

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We assess how your quality system supports GxP operations in practice:

Quality-management system (QMS) structure and documentation

SOPs, work instructions and training records

Change control, deviation, CAPA and periodic review processes

Roles, responsibilities and governance for GxP activities

We focus on alignment between written procedures and real behaviours.

Step 2

Computerised systems and infrastructure

We review against current CSV/CSA and Annex 11 expectations:

CSV / CSA methodology and validation packages across the system lifecycle

Configuration management, access control and audit-trail practice

Infrastructure qualification, monitoring, backup and recovery

Supplier responsibilities and service models for hosted and SaaS solutions

Where helpful, we sample specific systems in depth (for example, QMS, LIMS, MES, ERP, pharmacovigilance, serialisation or data platforms).

Step 3

Data integrity and data lifecycle

using ALCOA+ principles and data-lifecycle thinking:

Controls over creation, processing, review, reporting, archival and destruction of data

Audit trails, electronic signatures and access management

Backup, restore and disaster-recovery arrangements

Data-governance structures, including ownership and review

We look at both paper and electronic records, focusing on records that matter most for patient safety and product quality.

Step 4

Supplier and third-party audits

We conduct independent audits of SaaS, hosting and other external partners:

Evaluation of quality systems, service descriptions and SLAs

Review of contracts, responsibilities and technical and organisational controls

Assessment of how supplier practices align with your QMS and regulatory expectations

This supports both initial qualification and ongoing oversight of key suppliers.

Deliverables

Typical deliverables from a Process Modelling engagement include:

Audit plan and agenda

Scope, objectives, systems, sites, stakeholders, schedule, and methods.

Document-request list

Structured list of required records, SOPs, validation packages, and audit evidence.

Interview and sampling records

Notes from interviews and sampling, recorded consistently.

Audit report

Description of scope, methods, and observations, with findings risk-rated.

CAPA recommendations

Pragmatic actions with suggested priorities, owners and dependencies.

Supplier audit reports

Standalone reports for supplier qualification and oversight.

Executive presentation pack

Concise summary for senior management, suitable for inspections or board updates.

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Where requested, we can also provide follow-up support to shape detailed remediation projects or to validate completion of agreed actions.

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

Prioritised, risk-based remediation plan

Findings ordered by impact on patient safety, product quality and data integrity, with realistic actions and owners.

Stronger inspection readiness

Clearer narratives, better evidence and fewer surprises when inspectors or customers arrive.

Better alignment between Quality, IT and business

A shared, fact-based understanding of current state and of what “good enough” looks like.

More effective supplier oversight

An objective view of whether SaaS, hosting and manufacturing partners really meet your GxP expectations.

Input for portfolio and compliance planning

Audit results that feed directly into your compliance roadmap, risk register and project pipeline.

When to Consider GxP Audits

You need to prepare for a regulatory inspection or customer audit

You are assessing new or legacy computerised systems

You need to confirm the effectiveness of data-integrity and quality-management controls

You need to evaluate SaaS or hosting providers for GxP suitability

You are a software supplier and would like to become audit ready

You seek an independent view after major change or projects

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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.