Regulatory Authorities

  1. FDA 21 CFR Part 11 Guidance Document
    • Scope: Governs electronic records and signatures in FDA-regulated activities.
    • Relevance: Requires validation of cloud systems for data integrity, audit trails, and access controls for submissions like clinical trials or manufacturing records.
  2. EMA Annex 11 Guidelines (EU GMP)
    • Scope: Risk-based validation of computerized systems, including cloud infrastructure.
    • Relevance: Mandates infrastructure qualification, change control, and audit trails for EU pharmaceutical operations.
  3. WHO TRS 996 Annex 5 Guidelines (WHO GMP)
    • Scope: Global standards for GxP systems in drug manufacturing and quality assurance.
    • Relevance: Provides validation frameworks for cloud-based systems in low-resource settings.

Industry Standards & Frameworks

  1. ISPE GAMP 5 Guide (2nd Edition)
    • Scope: Risk-based lifecycle management of GxP computerized systems.
    • Relevance: Addresses cloud infrastructure qualification, agile validation, and third-party audits.
  2. ISO 13485:2016 (Medical Devices)
    • ISO 13485 Overview
    • Scope: Quality management systems for medical device manufacturers.
    • Relevance: Ensures cloud infrastructure supports traceability, risk management, and validation for medical device data.
  3. ISO/IEC 27001:2022 (Information Security)
    • Scope: Security controls for protecting data in cloud environments.
    • Relevance: Aligns with GxP requirements for encryption, access management, and incident response.
  4. NIST Cybersecurity Framework 2.0 Guide
    • Scope: Governance, risk management, and cloud security best practices.
    • Relevance: Guides encryption, threat detection, and shared responsibility models for GxP data.

Healthcare-Specific Compliance

  1. HIPAA Cloud Compliance
    • Scope: Protection of electronic Protected Health Information (ePHI) in the cloud.
    • Relevance: Mandates encryption, access controls, and BAAs for healthcare providers.
  2. ISO 27017 (Cloud Security)
    • Scope: Security controls for cloud service providers and customers.
    • Relevance: Ensures GxP data in cloud environments meets GDPR and HIPAA requirements.

Additional Resources

  1. KPMG GxP Cloud Implementation
    • Scope: Risk management, supplier audits, and continuous monitoring strategies.
    • Relevance: Outlines validation steps for cloud migration in life sciences.
  2. MHRA GxP Data Integrity Guide
    • Scope: Data integrity principles for cloud-hosted GxP systems.
    • Relevance: Aligns with FDA/EMA expectations for audit trails and metadata.
  3. PIC/S Guidance on Data Integrity
    • Scope: Global standards for data governance in cloud environments.
    • Relevance: Supports ALCOA+ principles for GxP records
  4. WHO Annex 4 (Validation)