CSV
Computerized System Validation
GAMP 5 · 21 CFR Part 11 · EU Annex 11 — in regulated industries, without validation, there is no data. CNWAYLab follows the GAMP 5 methodology baseline, providing full lifecycle validation services from URS to PQ, leaving no unanswered questions at audit time.
Six Core Capabilities
Across the full CSV computerized system validation journey, building a quantifiable, reusable, and evolvable engineering delivery system.
Risk-Based
Classify systems into GAMP 5 Categories 1-5 using the V-Model, focusing validation resources precisely on high-risk processes.
E-Signature
21 CFR Part 11-compliant two-factor electronic signature chain — signer, timestamp, meaning, and hash fully recorded.
Audit Trail
Field-level audit records with the complete quintuple: old value / new value / operator / context / business reason.
Data Integrity
ALCOA+ nine principles implemented: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available.
Validation Docs
URS / FS / DS / TM / IQ / OQ / PQ / SOP — the complete eight-document suite, customizable within 2 weeks.
Periodic Review
Full lifecycle management: annual post-launch Periodic Reviews, change control, decommissioning and archiving.
Functional Module Checklist
Every module is distilled from 400+ real projects — ready to use, no need to build from scratch.
URS User Requirements
Traceable requirements matrix + business use case library
FS / DS Design Specs
Functional specification, design specification, interface specification
Risk Assessment
FMEA + GAMP risk matrix
IQ Installation Qualification
Hardware, software, network, and dependency verification
OQ Operational Qualification
120+ standard test cases + boundary testing
PQ Performance Qualification
End-to-end validation under real business scenarios
Trace Matrix
Requirements-design-testing-defects four-way traceability
Validation Summary
Release report and residual risk statement
Standard Delivery Roadmap
7 standard phases, so clients know exactly what happens every week from week one.
Project Validation Plan & Organizational Authorization
Develop the Validation Master Plan (VMP), defining roles and responsibilities, validation scope, deliverables checklist, and milestone timeline.
Requirements Specification & Functional Specification Review
Draft the User Requirements Specification (URS) and Functional Specification (FS), then conduct a joint review to confirm complete traceability between design and requirements.
GAMP Risk Assessment & Test Strategy
Conduct system risk analysis based on GAMP 5, produce an FMEA matrix, and determine the test strategy and validation depth.
Installation Qualification · Environment Baseline
Verify correct installation and configuration of hardware, software, network, and dependencies. Establish environment baseline records.
Operational Qualification · Functional Test Cases
Execute 120+ standard test cases covering normal functions, boundary conditions, and stress scenarios. Confirm the system operates as designed.
Performance Qualification · Real-World Business
Execute end-to-end validation under real business scenarios and data volumes. Confirm the system meets intended use and performance targets.
Release Report · Go Live
Consolidate validation results, produce the Validation Summary Report and Residual Risk Statement. After quality sign-off, the system goes live into production.
Start Your Next Validation Project with Zero Risk
Book a 30-minute solution diagnostic. A CNWAYLab senior CSV consultant will deliver a tailored delivery proposal.
0 FDA 483 Warning Letters, 100% audit pass rate — this is our delivery baseline.