Scientific Data and AI Cloud Verification and Validation Strategy

This document is a technical report that outlines the Verification and Validation (V&V) strategy implemented by TetraScience for their products, including the Tetra Scientific Data and AI Cloud. It details the necessary deliverables to establish a validation baseline, which significantly reduces the validation burden on customers. The report describes the company's ISO 9001-certified Quality Management System and its alignment with various GxP regulations and standards. It explains the use of Infrastructure as Code (IaC) for automated provisioning and the Agile development methodology employed for verification and validation processes. Additionally, the document addresses the Computer Software Assurance (CSA) guidance, emphasizing the importance of leveraging supplier testing to ease the validation process. It also discusses the GxP impact assessment for new functionalities and the release process for updates, including the GxP package designed to accelerate validation for regulated customers. The report aims to provide clarity on the V&V strategy and its implications for compliance in regulated environments.