GAMP 5 Cloud Infrastructure Qualification Framework

GAMP 5 Cloud Infrastructure Qualification – Complete Reference

GAMP 5 Cloud Infrastructure Qualification Framework

Complete validation scope, 21 CFR Part 11 compliance, and ALCOA+ data integrity reference for XaaS deployment models

📋 About This Framework

This comprehensive reference tool provides pharmaceutical and biotech professionals with detailed guidance on validating cloud infrastructure under GAMP 5 (Good Automated Manufacturing Practice) guidelines. It covers validation scope, regulatory compliance (21 CFR Part 11), and data integrity principles (ALCOA+) across four deployment models: Traditional IT, IaaS, PaaS, and SaaS.

Vendor Managed – Covered by vendor qualification (IQ/OQ/PQ)
Customer Responsibility – CSV/validation deliverables required

Key Takeaways

  • Traditional IT: Full validation responsibility – complete control but highest compliance burden
  • IaaS: ~30% reduced scope – vendor manages infrastructure, customer validates application stack
  • PaaS: ~60% reduced scope – vendor manages platform, customer validates application and data
  • SaaS: ~80% reduced scope – vendor manages everything, customer validates configuration and data governance
📋 GAMP 5 Validation Strategy

⚖️ 21 CFR Part 11 – Electronic Records; Electronic Signatures

FDA regulation establishing criteria for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. Key requirements include system validation, audit trails, record integrity, and access controls.

⚖️ 21 CFR Part 11 Compliance Implementation

🔒 ALCOA+ Data Integrity Principles

ALCOA+ is the international standard for data integrity in regulated industries. Originally ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate), the “+” adds Complete, Consistent, Enduring, and Available. These principles ensure data quality throughout its lifecycle.

🔒 ALCOA+ Data Integrity Controls
📊 Comprehensive Comparison Matrix
Aspect Traditional IT IaaS PaaS SaaS
Validation Scope Complete infrastructure from hardware to application Application stack + vendor qualification review Application layer + data management Configuration validation + vendor assessment
GAMP Category Category 4 (Custom System) Category 4 (Application) + Category 1 (Infrastructure) Category 4/5 + Category 3 (Platform) Category 3/5 (Configurable Product)
IQ Focus Hardware installation, network setup, server configuration VM configuration, OS installation, vendor IQ review Application deployment, platform configuration Vendor certificates, SOC 2, ISO 27001 review
OQ Focus All system parameters, performance, security Application tier, OS config, network performance Application functions, integrations, data validation Configuration settings, user access, workflows
PQ Focus End-to-end process validation, full data lifecycle Production scenarios, audit trails, redundancy Data integrity, 21 CFR Part 11, audit logs Application-level data integrity, audit testing
Audit Trail Custom development required Application-level + CloudTrail/Azure Monitor Application + platform logging services Native SaaS audit logs (review capabilities)
Data Security AES-256, TLS 1.3, custom key management Customer-managed keys, VPC isolation, encryption Transparent data encryption, managed keys Vendor encryption (review key management)
Business Continuity Custom DR solution, RPO/RTO as designed Multi-AZ, cross-region replication (customer config) Platform HA, automated backup (managed) Vendor SLA (99.9%+), vendor-managed BC/DR
Validation Effort Baseline (100%) ~70% of Traditional IT ~40% of Traditional IT ~20% of Traditional IT
Primary Risk Complete responsibility for all layers Shared responsibility complexity Platform dependency, limited infrastructure access Heavy vendor reliance, update management
Best For Legacy systems, maximum control requirements Custom applications, flexible infrastructure needs Rapid development, standardized applications Commercial software, minimal IT overhead

Validation Strategy Selection Guide

  • Choose Traditional IT when: Maximum control required, legacy infrastructure, no cloud migration option, complete data sovereignty needed
  • Choose IaaS when: Custom applications with specific infrastructure needs, gradual cloud migration, need infrastructure flexibility
  • Choose PaaS when: Focus on application development, standardized platforms acceptable, rapid deployment needed
  • Choose SaaS when: Commercial off-the-shelf solution available, minimal IT overhead desired, vendor has strong compliance credentials