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Computer System Validation (CSV)

Module 1 — Site & Investigator Intelligence | GAMP 5 Category 5

Document pack version 1.0 — April 2026

Scope: This CSV pack covers ClinicalOS Module 1 (Site & Investigator Intelligence) only. Module 1 is classified as a decision support tool (not a GxP system of record). Validation follows GAMP 5 Category 5 (custom application) and ICH Q9 risk-based approach.
COS-CSV-URS-001Approvedv1.0

URS — User Requirements Specification

Exhaustive list of what Module 1 must do. Functional and non-functional requirements with acceptance criteria.

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COS-CSV-FS-001Approvedv1.0

FS — Functional Specification

How each URS requirement is implemented. Data flows, algorithms, scoring rules, API contracts.

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COS-CSV-DS-001Approvedv1.0

DS — Design Specification

Technical architecture, database schema, API design, security controls, deployment topology.

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COS-CSV-TM-001Approvedv1.0

TM — Traceability Matrix

Bidirectional mapping: URS → FS → DS → Test Cases → Results.

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COS-CSV-IQ-001Approvedv1.0

IQ — Installation Qualification

Verification that infrastructure is deployed correctly: GCP, Cloud SQL, Cloud Run, networking.

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COS-CSV-OQ-001Approvedv1.0

OQ — Operational Qualification

Functional tests: every Module 1 feature tested formally. Security, auth, RBAC, encryption verified.

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COS-CSV-PQ-001Approvedv1.0

PQ — Performance Qualification

Validation in production conditions with real data: response times, accuracy, user acceptance.

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Regulatory Framework

Applicable Standards

  • GAMP 5 — A Risk-Based Approach to GxP Compliant Systems
  • ICH Q9 — Quality Risk Management
  • 21 CFR Part 11 — Electronic Records & Signatures
  • EU Annex 11 — Computerised Systems
  • ICH E6(R3) — Good Clinical Practice

Document Control

  • Author: ClinicalOS Engineering
  • Reviewer: Quality Assurance
  • Approver: Validation Lead
  • Effective date: April 2026
  • Review cycle: Annual or upon major change