Validation Master Plan ( VMP )
Defines scope, objectives, responsibilities, and the validation strategy. It anchors the lifecycle planning phase. See the validation lifecycle for when it is produced.
CSV for GxP
Key Validation Documents in CSV and Their Contents
CSV deliverables provide traceable evidence that a system is fit for use. Each document plays a specific role in the lifecycle and supports regulatory inspection readiness.
User Requirements Specification ( URS )
Lists business and regulatory requirements in user language. It drives configuration decisions and is the basis of traceability testing.
Functional & Design Specifications ( FS / DS )
Describe how the system meets the URS . FS covers functional behaviors; DS outlines architecture, configuration, and technical design decisions.
Risk Assessment
Documents system risks and mitigations. It establishes which features require rigorous testing and ensures validation effort matches risk.
IQ / OQ / PQ Protocols & Reports
Test scripts and evidence for installation, operational, and performance qualification. These reports capture results, deviations, and approvals.
Requirements Traceability Matrix ( RTM )
Maps each requirement to test evidence and confirms full coverage. The RTM connects requirements, risks, and test cases.
Validation Summary Report
Summarizes validation activities, results, and deviations. It provides the formal release decision for system use.
Change Control & Periodic Review Records
Record ongoing system changes, impact assessments, and periodic reviews that keep the system in a validated state.
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