The Octet® Software Validation Package is designed for laboratories using Octet® Software Version 14 with the Octet® Compliance Suite and Compliance Hub operating in regulated environments where they are responsible for software validation within their own quality system.
**What's Included:**
• Validation User Guide – Defines scope, framework, and customer responsibilities aligned to regulatory requirements
• Software Validation Test Scripts – Tests for user/role permissions, access controls, audit trail behavior, electronic signatures, and security settings
• Analysis & Calculation Verification – Workflows for confirming kinetics and quantitation curve fits and data preprocessing checks
• Example Datasets & Test Files – Octet® data files, analysis settings, and test folders for result confirmation and reproducibility
• Reusable Validation Artifacts – Templates and worksheets for evidence capture, documentation, and audit-ready reporting
**Intended For:**
• Laboratories operating under GxP requirements (GLP, GMP)
• QC, QA, and regulated development teams
• Organizations subject to FDA 21 CFR Part 11 regulations
• Validation, quality, and IT teams responsible for software qualification
**Note:** This package does not include Sartorius personnel performing validation and is not a substitute for IQ, OQ, or PQ. Regulatory compliance remains the customer's responsibility.