Computer system validation
CSV is the craft underneath everything else on this site: nearly 20 years of validating the systems pharma actually runs on, from LIMS and eQMS to ERP and the shop floor. This page explains the discipline, and how the delivery work runs.
What is computer system validation?
Computer system validation (CSV) is the documented process of establishing that a computer system does what it is intended to do, reliably and in compliance with GxP regulations. It runs the full lifecycle: user requirements, risk assessment, specification, testing through IQ, OQ and PQ, release, and the periodic review that keeps the validated state alive. The regulatory spine is 21 CFR Part 11, EU Annex 11, GAMP 5 and the data integrity expectations of the FDA, MHRA and WHO.
What systems does it cover?
Every GxP layer. Manufacturing systems such as MES, EBR and SCADA. Laboratory systems: LIMS, chromatography data systems, ELN and instruments. Quality systems: eQMS, document management and training platforms. Enterprise systems: ERP including SAP S/4HANA, serialization and regulatory information management. Plus the infrastructure they run on, including cloud, and the migrations between them, where validation most often gets skipped and most often gets caught.
How the delivery work runs
TrustBridge takes CSV work as fixed-scope projects or a day-rate lane: validation strategy and master plans, GxP and Part 11 risk assessments, IQ, OQ and PQ protocols and execution, migration and upgrade validation, and the SOPs that hold it together. The delivery is risk-based by default, which today means CSV done to the CSA standard: critical thinking documented, testing sized to risk, and data integrity built in rather than bolted on. Where the estate is large, the paperless validation lane takes the same work digital.
Proof from the field
Inspections passed with no data-integrity findings on the systems this practice shaped, a validation portfolio led at the €40M scale, and validation cycle times improved by up to 45% on enterprise programmes. The full track record is on the about page.
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Questions teams ask
What is the difference between computer system validation and CSA?
CSV is the discipline; CSA is the modern, risk-based way to practise it. Computer Software Assurance, finalised by the FDA in September 2025 and updated in February 2026, keeps CSV's intent, establishing confidence in the system, while sizing the evidence to function-level risk instead of documenting everything equally. New work should be done the CSA way; the discipline is still validation.
Do cloud and SaaS systems need CSV?
Yes, with the scope split along the shared-responsibility line: the vendor qualifies what they control, you validate your intended use, configuration and data on top. The practical method, including supplier assessment and continuous-release handling, is on the GxP cloud validation page.
Can you rescue a validation that an audit has already questioned?
Usually, and faster than a full revalidation. The approach is a gap assessment against the actual finding, a risk-based remediation plan an inspector can follow, and evidence rebuilt where it matters first. Bring the finding to a conversation and you will get an honest read on the effort.
Validation that holds up when someone checks
Bring the system, the deadline or the finding. You leave the first call with three concrete next moves.
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