Computer System Validation Document

Based on Nettleton D, Gough J. "Computer System Validation for SaaS and Cloud Computing."
Davis Healthcare International, 2020  ·  ISBN: 978-1-942911-49-4
View Publication at PDA Bookstore
Futureprism Platform — Clinical Research Management System
DRAFT v1.0
Document ID
VAL-FP-2026-001
Version
1.0 — Draft
Date
2026-04-13
Classification
Confidential — Auditor Distribution
Prepared By
Validation Team
Regulatory Framework
21 CFR Part 11, 21 CFR Part 21, GAMP 5, FDA CSV Guidance

Table of Contents

0Front Matter & Checklist §1System Purpose & Scope §2Regulatory Applicability §3System Architecture Overview §4Component Inventory §5Data Flow & Integration Diagrams §6Security & Access Controls §7Audit Trail & Logging §8Data Integrity & Privacy Controls §9Infrastructure & Deployment §10Qualification (IQ/OQ/PQ) §11Risk Assessment & Hazard Analysis §12Change Control Procedures §13Periodic Review Schedule AGlossary BRegulatory References CDocument Approval
0 Front Matter — Revision History & Validation Checklist
Document revision tracking and auditor validation checklist summary.
Document Revision History
VersionDateAuthorDescription
1.02026-04-13Validation TeamInitial draft — system overview, architecture, test cases
Validation Checklist Summary
Instructions to Auditor: Each section below corresponds to a numbered chapter in this document. Check each item as reviewed. All test cases appear in Section 10 (Qualification) as executable checklists.
#Validation AreaSectionStatus
1System Purpose & Scope§1Pending
2Regulatory Applicability§2Pending
3System Architecture Overview§3Pending
4Component Inventory§4Pending
5Data Flow & Integration Diagram§5Pending
6Security & Access Controls§6Pending
7Audit Trail & Logging§7Pending
8Data Integrity & Privacy Controls§8Pending
9Infrastructure & Deployment§9Pending
10Installation Qualification (IQ)§10.1Pending
11Operational Qualification (OQ)§10.2Pending
12Performance Qualification (PQ)§10.3Pending
13Risk Assessment (Hazard Analysis)§11Pending
14Change Control Procedures§12Pending
15Periodic Review Schedule§13Pending
Auditor Signature: ______________________________
Date: ______________
Reviewer Signature: ______________________________
Date: ______________
10 Qualification Test Cases (IQ / OQ / PQ)
Installation, Operational, and Performance Qualification test cases including Caracal mobile framework.
10.1 Installation Qualification (IQ)
Purpose: Verify that all system components are installed correctly in the designated environment with specified configurations. Includes Caracal mobile framework components.
10.2 Operational Qualification (OQ)
Purpose: Verify that the system functions correctly in accordance with its operational specifications in the installed environment. Includes Caracal mobile framework UI components.
10.3 Performance Qualification (PQ)
Purpose: Verify the system performs reliably under real-world operational conditions.

End of Document — VAL-FP-2026-001 v1.0

Futureprism Platform — Computer System Validation Document | Confidential — Auditor Distribution

21 CFR Part 11 | 21 CFR Part 21 | GAMP 5 | FDA CSV Guidance