Description
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.
