GXP Qualification, validation and Computerised System Validation for life sciences and other regulated industries
Validate with vision.
Anticipate with precision.
Validation is protection
Protection through processes
Validation in life sciences and other heavily regulated sectors should be more than a box-ticking exercise. Done right, it can pave the way to a better way of working, laying the foundations for future resilience and success. Our work protects your business. We help life science and other regulated industry clients regulate complex GxP frameworks across the full lifecycle of their systems, from design through to refinement and ongoing operations. With structured methods, guided digital transformation, interdisciplinary collaboration, and audit-ready documentation designed to stand the test of time, we turn compliance and process optimisation into a tangible advantage. No two organisations or processes are the same, and nor are our strategies. Our services span three main areas, with flexible support available to support your evolving needs.
21 CFR Part 11 has existed unchanged since the days of the floppy disk. Today, AI, cloud services, and automated labs are changing the rules. Our in-depth understanding of the regulations and their implementation allows us to tailor our approach to our clients’ individual requirements.
GxP Computerised System Validation
Digitalised processes.
Validated computerised systems.
Anticipated outcomes.
Our experienced team of engineers, scientists, and validation experts work at the intersection of science, technology, and regulatory compliance. We ensure integrity and compliance through documented and thoroughly validated processes. Wherever and whenever you need us, we are there to provide support, a helping hand, and lasting peace of mind.
It’s our job to prepare for the worst. Not because we think it will happen, but because everything potentially could… And you need to be ready. When the server dies, or a drug is recalled, you don’t want to be standing there wishing you’d prepared better. We help you proactively manage every risk imaginable – with end-to-end validation, qualification, and inspection-ready processes.
It’s our job to prepare for the worst. Not because we think it will happen, but because everything potentially could… And you need to be ready. When the server dies, or a drug is recalled, you don’t want to be standing there wishing you’d prepared better. We help you proactively manage every risk imaginable – with end-to-end validation, qualification, and inspection-ready processes.
Define
Questioning the status quo.
Anticipating needs.
We map your current processes and define requirements to reduce risk and unlock business benefits.
Evaluate your business processes
- Spotting bottlenecks, understanding why they exist.
- Digitally mapping workflows and processes.
- Facilitating change for efficiency and resilience.
- Identifying paper records and spreadsheets for elimination.
Risk assessment
- Identifying data vulnerabilities and criticality.
- Defining risk mitigation strategies.
- Redesigning processes and leading digital transformation to reduce exposure.
- Ensuring data integrity.
Requirements engineering
- Evaluating and documenting user, stakeholder, and business needs.
- Mapping requirements to key regulations, such as 21 CFR Part 11, GMP predicate rules.
Compliance assessment
- Assessing software compliance with 21 CFR part 11 /applicable predicate rules and EU GMP Annex 11.
- Covering technical, administrative, and procedural controls.
- Closing gaps between capability and regulatory expectations.
Project management
- Planning, coordinating, and controlling validation and qualification activities from start to finish.
- Always ensuring risks are identified early for prompt mitigation.
- Building compliance into every process step.
Build
Validating and building.
Integrating GxP compliance.
We implement and qualify systems, equipment, and infrastructure for resilient, reliable, and fully compliant operations.
AISQ and CSV
- Aligning validation against applicable regulations and guidelines, including USP 1058, GAMP 5, and more.
- Ensuring regulatory readiness and fitness for purpose.
- Establishing structured and repeatable validation processes.
Equipment and system qualification
- Qualifying production equipment from design to performance (DQ, FAT, SAT, IQ, OQ, and PQ).
- Documenting every stage in line with Annex 15, ICH guidelines, and your company’s VMP.
- Confirming systems operate effectively in your operational context.
Automation and integration
- Integrating automation into your workflows for accuracy and speed alongside full compliance.
- Configuring and validating API-driven workflows, custom software, and robotics solutions – including mobile robots (cobots).
- Testing every sequence and interface for assured reliability.
Interface validation
- Specifying functionality and data transfer integrity requirements.
- Verifying every point of data exchange between systems.
- Validating error handling and ensuring information moves with accuracy, traceability, and security from start to finish.
Infrastructure qualification
- Confirming servers, networks, and IT infrastructure are resiliant with high fault tolerance.
- Specifying and qualifying the underlying infrastructure to confirm robustness and support for validated systems.
- Minimising the risk of downtime, operational failure, and associated reputational and compliance risks.
Assure
Maintaining compliance.
Integrating continual improvement.
We maintain compliance, safeguard data integrity, and support continual improvement – keeping your systems aligned with CGMP for lasting audit-ready resilience.
Data integrity
- Implementing audit trail review strategies and electronic signatures (e-signatures).
- Strengthening trust in data through digitalisation and secure processes.
- Anchoring data integrity in the foundations of every system.
Analytical methodology
- Developing, validating, and implementing processes in alignment with ICH and USP guidance.
- Supporting robust, reliable scientific and operational results.
Testing and SOPs
- Conducting functional, performance, usability, and UAT testing.
- Stress testing to reveal vulnerabilities and opportunities for optimisation.
- Composing lean and practical SOPs that reflect real workflows.
Documentation and investigations
- Preparing validation and qualification protocols, reports, and CAPA documentation.
- Managing deviations, OOS results, complaints, and investigations effectively.
Ongoing compliance and cloud
- Keeping systems aligned with evolving regulations and guidance.
- Qualifying and validating AWS, Azure, and private cloud environments.
- Maintaining inspection-readiness and continuous operational integrity.
Cloud qualification and validation
- Qualifying and validating AWS, Azure, and private cloud environments to meet regulatory demands.
- Validating cloud services as required to ensure fitness for purpose.
- Securing digital infrastructure to ensure it remains reliable, compliant, and inspection-ready.
Data integrity and cloud compliance
- Implementing audit trails, electronic signatures (e-signatures), and validated cloud environments – AWS, Azure, and private clouds.
- Ensuring ongoing compliance with regulations and internal standards.
- Enabling careful digitalisation with full compliance.
You can’t validate what you don’t understand – that’s why we dive into every detail. We thrive where chemistry, biology, engineering and innovation intersect. We live for the challenge – unmasking hidden issues, optimising workflows, and ensuring each process is compliant and efficient.
Work with Validview
Validated partnership.
Validated results.
On-demand validation
Ad-hoc support
Precise integration
On-site and remote integration
Contracted for compliance
Project and contract work
Contact to contract
Contact us today
Got a GxP project on the horizon? Or a burning need right now? Contact our validation specialists today for a free and non-binding initial conversation.
