Documentation: Guideline

The key purpose of this document is to provide requirements for Good Documentation Practices and define the standard with respect to format, content and handling of document types within Informatics. This Supporting Document must be read in conjunction with Informatics Document Standards SOP (VQD: S

and Scope This document provides guidance on testing and sampling strategies for GenAI sub-systems. This document provides best practices and guidelines to help meet the expectations defined in Group Informatics Generative AI Computerised Sub-system Validation Lifecycle SOP Generative AI Sub-system

The purpose of this document is to provide the list of terms for the Computerised System Glossary (see Appendix 1) and describe a standardized process for maintaining and managing it. Additionally, this document describes the different key roles relevant to this process. This document applies to all

The purpose of this document is to provide a framework for the definition of a risk-based testing approach in support of the requirements as per the Computerised System Risk Management SOP. This document applies to all computerised systems (CSs) that are built, deployed and/or maintained by Roche In

This document provides a structured approach to assess vendors of computerized systems and services as part of the Vendor Quality Assessment (VQA) process. It is intended to evaluate the Vendor's quality governance, data integrity capabilities, and ability to support GxP-compliant operations for Roc