Compliance for life sciences
Joining up processes, systems, infrastructure and data so GxP compliance is built in, not bolted on.
Pharmaceutical, biotech and medical-device organisations now run complex combinations of on-premise, cloud and SaaS systems across laboratories, manufacturing, quality and commercial operations. Regulators expect all of this to operate in a controlled, inspection-ready state – supported by clear processes, qualified infrastructure, validated systems and robust data integrity.
In reality, gaps often appear at the joins: processes that exist only in people’s heads, systems validated once but not kept current, infrastructure that is not clearly qualified, or data that does not fully meet ALCOA+ expectations. These gaps show up as inspection findings, remediation projects and operational noise.
Amalia’s Compliance services bring these elements together. We map how work really happens, validate and qualify the technology that supports it, assess your GxP landscape through independent audits and strengthen data integrity across the lifecycle. The aim is practical, risk-based compliance that protects patients and products while still allowing you to move at pace.
Why Compliance Matters
Good Practice (GxP) guidelines – GMP, GDP, GCP, GLP and GVP – together with ICH Q7, Q9 and Q10, define how life-sciences organisations must control quality, data and risk. At the same time, regulators such as FDA, EMA, MHRA and PIC/S have sharpened expectations on computerised systems, infrastructure and data integrity, embedding ALCOA+ principles across the full data lifecycle.
fragmented decision-making and opaque priorities
inconsistent ways of working across projects and teams
late discovery of dependencies, risks and regulatory implications
stalled strategic initiatives while tactical work soaks up capacity
difficulty proving value for money or learning from experience
Demonstrate how processes, systems, and data-lifecycle controls ensure patient safety, quality, and integrity.
Focus effort where risk is highest using risk-based CSV/CSA and infrastructure qualification.
Gain an independent, evidence-based view of your GxP position through audits
Build a sustainable data-integrity culture aligned with ALCOA+ and data-lifecycle expectations
Services within Compliance
Process Modelling clarifies how GxP-relevant work actually flows through your organisation – from triggers and inputs to tasks, decisions, hand-offs and outputs. We work with subject-matter experts and front-line teams to map as-is processes, identify pain points and risks, and co-design to-be processes that are simpler, more controllable and better aligned with your quality and business goals.
We then connect processes to roles, systems, data and controls, and help you embed a process library into your tools and governance so it stays current and usable.
Clear, standard process maps that show how work and controls flow end to end
A shared picture for business, quality, IT and suppliers to use in change, training and decision-making
A reusable process library that supports implementations, audits, optimisation and continuous improvement
Our GxP Software Validation service combines modern Computerised System Validation (CSV) and Computer Software Assurance (CSA) approaches. Using GAMP 5 Second Edition, FDA CSA guidance and ICH Q9 principles, we design and run validation that focuses effort on functionality and data flows with real impact on patient safety, product quality and data integrity.
We help you understand system context, define a risk-based validation strategy, specify requirements and risks, plan and execute proportionate testing, and manage deviations and traceability so your validation story is coherent and inspection-ready.
A structured CSV/CSA approach aligned with 21 CFR Part 11, EU GMP Annex 11/15 and GAMP 5 Second Edition
Right-sized testing and documentation, with effort driven by risk rather than habit
Validation packages that stand up to inspection and support faster, safer go-lives and changes
GxP Infrastructure Qualification ensures that the platforms supporting your validated systems – on-premise, cloud or hybrid – are demonstrably fit for purpose and kept in a controlled state. We define a risk-based IQ strategy, assess vendors and service providers, build inventories and classifications, and develop specifications for availability, security, data integrity, backup and recovery.
We then plan and support commissioning and qualification (IQ/OQ), make intelligent use of vendor evidence, and set up change and lifecycle processes so your qualified state can be maintained without excessive overhead.
A clear, defensible picture of GxP-relevant infrastructure and its qualified status
Risk-based IQ/OQ and documentation that align with EU GMP Annex 11/15, 21 CFR Part 11 and GAMP infrastructure guidance
Practical processes to keep infrastructure controlled and inspection-ready through change, patching and new projects
Our GxP Audits service provides an independent, risk-based view of your compliance position across quality systems, computerised systems, infrastructure, data lifecycle and suppliers. We tailor the audit scope to your context, reviewing QMS design, SOPs and training, CSV/CSA practices, infrastructure controls, ALCOA+ data-integrity measures and the way SaaS and hosting partners support your obligations.
Findings are documented and risk-rated by impact on patient safety, product quality and data integrity, and translated into pragmatic corrective and preventive actions, with the option for follow-up support.
An objective, risk-based assessment of where you stand against GxP expectations and data-integrity guidance
A prioritised remediation plan with clear actions, owners and timelines
Stronger inspection readiness and more effective oversight of key suppliers and systems
Data Integrity sits at the heart of GxP compliance: if you cannot trust your data, you cannot trust your products, processes or reports. We conduct ALCOA+-aligned data-integrity assessments for systems and processes, looking at data flows, roles, access, audit trails, interfaces and lifecycle controls across both paper and electronic records.
Based on this, we design lifecycle-based controls, clarify ownership, integrate data-integrity risk into CSV/CSA and develop remediation roadmaps that prioritise issues by impact on patient safety, product quality and data integrity
ALCOA+-aligned, lifecycle-based controls embedded into day-to-day operations, not just project documents
Clear ownership and accountability for critical GxP data across Quality, IT and the business
Stronger inspection readiness, with a coherent data-integrity narrative and evidence base across systems and sites
How it all fits together
Compliance is strongest when these services operate as one coherent model rather than isolated initiatives.
provides the operational backbone: a shared view of how work is meant to happen, where controls sit and which records matter most. This underpins both validation and audit activities.
then validates the systems that support those processes, using risk and data-lifecycle insights to focus testing and documentation where it matters most.
ensures that applications run on qualified, controlled platforms, so inspectors can trace compliance from hardware and cloud services through to system behaviour and records.
provide an independent check across this landscape – systems, infrastructure, processes, data and suppliers – feeding directly into your risk register, CAPA plans and compliance roadmap
cuts across all of the above, ensuring that ALCOA+ and data-lifecycle thinking are embedded into processes, systems, infrastructure and audits rather than treated as an afterthought.
Customer Stories & Insights
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.
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.
A single, senior, cross-functional team replaces multiple vendors. Fewer hand-offs, faster delivery, and one accountable partner throughout.
We align leadership, QA, IT and operations around shared decisions. Clear reasoning, documented outcomes, and no misalignment.
Solutions are built around real processes and real risk. Practical delivery that avoids shelfware and drives measurable outcomes.
We bring global experience and adapt it to your specific context and operating reality. Proven frameworks, applied flexibly where they matter most.
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.