Computerized System Validation
Ensuring compliance and confidence in your GxP systems
Computerized systems play a critical role in regulated environments, supporting everything from clinical data management to quality processes. Ensuring these systems are validated and compliant is essential to maintain data integrity, patient safety and regulatory trust.
Moreover, it is inevitable that also ICH GCP E(6) and ISO 14155:2026 are now setting clear expectations on this topic: robust data governance and fit-for-purpose systems are no longer optional.
Computerized System Validation (CSV) is what transforms “the system probably works” into documented, demonstrable assurance that your data is reliable and compliant, aligned with the ALCOA+ principles.
At XPER Research, we provide end-to-end Computerized System Validation (CSV) support, helping you implement and maintain compliant, inspection-ready systems aligned with global regulations and industry best practices. Including but not limited to: GxP, FDA 21 CFR Part 11, EU Annex 11, ISO 14155:2026 and GAMP® 5
Why CSV matters
A robust CSV framework helps you:
- Ensure data accuracy, integrity and traceability
- Demonstrate compliance with regulatory expectations
- Reduce operational and compliance risks
- Support successful audits and inspections
- Enable reliable decision-making based on validated systems
Our Approach
We deliver a risk-based, scalable validation approach aligned with GAMP® 5 principles, tailored to your system landscape and organizational needs.
Our certified specialists ensure that clinical systems such as eTMF, eCRF, CTMS, e‑signature platforms and other GxP‑relevant tools are validated, audit‑ready and compliant with EU requirements. Moreover, support in building or strengthening your organizational CSV framework is something we can help with.
Our services include:
- Defining or improving your organizational CSV framework
- Support in determination of validation strategy and planning, verification, reporting and release for specific CSV projects
- Set-up of specific system and CSV-project documentation
- Service provider assessment and audit support
- Change control, periodic review, and validation maintenance
- Audit and inspection readiness support
We work closely with your teams to ensure validation activities are pragmatic, efficient, compliant and aligned with your quality management system.
Why partner with us
Our team combines regulatory expertise with hands-on operational experience across clinical research, computerized and quality systems.
We offer:
- Pragmatic, risk-based validation methodologies
- Flexible support, from standalone deliverables to full lifecycle management
- A collaborative approach focused on delivering practical, audit-ready solutions
Let’s ensure your systems are compliant and future-proof
Whether you are implementing a new system, upgrading existing infrastructure, or preparing for an inspection, we support you every step of the way.
