Computer System Validation (CSV)

Computer system validation (CSV) confirms that systems used in GxP environments perform as intended and produce trustworthy records for FDA-regulated work. That includes clinical, quality, manufacturing, laboratory, and safety systems where electronic data support decisions, release, or submissions. Viltis consultants help teams apply risk-based validation so effort matches system criticality, complexity, and 21 CFR Part 11 expectations without padding the package with low-value testing.

A sound CSV approach starts with intended use and risk. Not every configuration change needs the same depth of testing, but every GxP-relevant system needs clear requirements, controlled access, audit trails where required, and documented evidence that critical functions work. We help clients define validation plans, assess vendor documentation for SaaS and cloud platforms, and identify where configuration, interfaces, or custom reports create residual risk that still needs independent testing and clear ownership.

Documentation quality matters as much as test execution. Protocols should state what is being tested and why; scripts should produce objective pass or fail results; and deviations during validation need CAPA-style closure before go-live. Change control after release should trigger impact assessment and, when needed, revalidation so the validated state does not quietly erode over successive upgrades, patches, or vendor-driven cloud releases that alter GxP-relevant behavior.

Viltis supports CSV as consulting and specialist resources embedded with your IT, quality, and business owners. We do not certify systems or issue regulatory certificates on behalf of vendors or sponsors. Deliverables typically include validation plans, risk assessments, protocol and report packages, and Part 11 gap notes that fit your SOP framework and the story you will tell in an FDA or client inspection.

Typical computer system validation activities include

• Validation planning and GxP risk assessment by system and process
• Part 11 and electronic record control evaluations
• SaaS, cloud, and on-premise validation support
• Requirements, IQ/OQ/PQ or equivalent protocol development
• Change control impact assessment and revalidation planning
• Validation documentation review for inspection readiness

If a new QMS, LIMS, EDC, or manufacturing system is going live, or an audit flagged weak CSV evidence, we can help rebuild the package with clear ownership and traceable testing. Contact Viltis to scope the systems that need attention first and how validation work fits your release calendar.