Validation and Compliance Considerations for Using Benchling as a GxP SystemT able of Contents 1 EXECUTIVE SUMMARY 2 INTRODUCTION 3 SECURITY & PRIVACY Enterprise Security Infrastructure Security Threat Detection Disaster Recovery and Business Continuity Plan Data Protection and Retention 4 PRODUCT FEATURES & CONTROL Identity and Access Management Records and Audit Logs Electronic Signatures Use Case 5 VALIDATION AND UPDATES Software Development Lifecycle Infrastructure Qualification Initial Validation Maintaining Validation (Upgrades and Patches) 6 AUDIT AND INSPECTION SUPPORT 7 QUALITY MANAGEMENT SYSTEM Resource Management and Employee Training Vendor Management Risk Management Change Management Document Management CAPA 8 CONCLUSION Benchling: Considerations for Using Benchling as

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