Computerized System Validation
We prove, with documented evidence, that your GxP system does what it should — consistently.
Computerized System Validation (CSV) proves, with documented evidence, that a GxP system operates consistently and per its intended use — protecting patient safety, product quality and data integrity.
Not every system needs validation: effort concentrates on GxP-relevant systems, those affecting product, quality, patient safety or data integrity. The GAMP category (1, 3, 4, 5) sets the depth of the lifecycle.
We adopt the risk-based approach of GAMP 5 (2nd edition) and the logic of Computer Software Assurance (CSA): more critical thinking and risk-driven testing, less paperwork with no value.
Deliverables cycle
URS & Initial Risk Assessment
The User Requirements Specification (URS) clearly and objectively defines everything the system must meet — drafted by a multidisciplinary team and approved by Quality Assurance. Alongside it, the initial risk assessment decides whether the system is GxP-relevant, and thereby the scope and depth of validation.
Validation Plan
Records the standards, methodology, team and release strategy across the lifecycle. Started at the earliest opportunity and revised at later stages; in agile approaches, it details release by sprints and configurations.
Specifications (FS/DS)
The functional specification clearly describes what the system does to meet the URS; the design specification details the infrastructure it runs on. Both are traced to each requirement and can be contractual documents between client and supplier.
IQ/OQ/PQ Protocols & Scripts
Protocols and scripts guiding installation, operation and performance testing, with scope, sampling, acceptance criteria and failure handling. Test rigor is proportional to GxP risk — more documented challenges where impact is greater.
Traceability Matrix
Links requirement, risk, specification and test evidence end to end. Ensures no requirement is orphaned, that each evidence points to a real need, and eases impact assessment of any future change.
Final Validation Report
Consolidates the results of all test phases and formally declares the validated state, per the Validation Plan strategy. From its approval, the system becomes subject to change control.
How we run it
Plan & assess risk
URS, GxP triage and validation plan.
Specify
FS/DS and traceability matrix.
Verify
Risk-driven IQ/OQ/PQ with deviation handling.
Release & maintain
Final report, validated state and change control.
Applicable standards
Frequently asked questions
Do I need to validate every system?
No. Only GxP-relevant systems — those affecting product, quality, patient safety or data integrity. We do the triage for you.
Do you work with supplier packages?
Yes. We review the manufacturer documentation and complete the remaining cycle to the validated state.
Does CSA replace CSV?
CSA is an evolution of CSV: more critical thinking and risk-focused testing. We apply both depending on the system.