Documentation: SOP

This document describes the stages in a computerised system's lifecycle where risks need to be evaluated. The purpose of these assessments is to provide the rationale for risk based activities and to facilitate communication of the risks. This document applies to all computerised systems being imple

The purpose of this document is to provide requirements for the implementation of AI agents in GxP applications. AI agents have greater capabilities that necessitate the establishment of internal governance frameworks and structured processes to account for the specific risks associated with agents.

The aim of this document is to provide the necessary and sufficient level of detail to describe the Incident Management process, to enable process performers to understand their role and their interaction with other roles within the process. This document defines the relationship of Incident Managem

The purpose of this document is to define the required activities to be performed and deliverables to be produced as part of the GxP validation lifecycle of an AI sub-system of an overarching computerised system supporting GxP business processes and data. This document applies to all computerised sy

The purpose of this process is to align, harmonize and integrate all the activities and information associated to the governance and maintenance of the Roche Computerized System Validation (CSV) Policies, Directives, SOPs and supporting materials (further referred to as Roche CSV process) in one com

This Standard Operating Procedure (SOP) describes the required activities to be performed and the required deliverables to be produced during the implementation of the computerized systems supporting GxP business process(s) and data. The SOP defines the minimum controls that must be adhered to meet

This Standard Operating Procedure (SOP) describes the required activities to be performed and the deliverables to be produced throughout the Operations and Maintenance phase of the Computerised System Validation (CSV) lifecycle. The SOP defines the minimum controls that must be adhered to meet the r

This Standard Operating Procedure (SOP) describes the activities to be performed and the deliverables to be produced throughout the retirement phase of a Computerised System Validation (CSV) lifecycle. The SOP defines the minimum controls that must be adhered to meet the requirements of Computerized

The purpose of this Standard Operating Procedure (SOP) is to define the required activities to be performed and deliverables to be produced as part of the GxP validation lifecycle of a Generative AI (GenAI) sub-system of an overarching computerised system supporting GxP business processes and data.

The aim of this document is to provide the necessary and sufficient level of detail to describe the Problem Management process, to enable process performers to understand their role and their interaction with other roles within the process. This document defines the relationship of Problem Managemen

This Standard Operating Procedure (SOP) describes the required activities to be performed and the required deliverables to be produced for the qualification of IT infrastructure components/solutions/platforms (hereafter referred to as component(s)/solution(s)/platform(s)) whenever the IT infrastruct

This SOP describes activities and deliverables for the Periodic Review process which is required to determine whether or not a computerized system or IT Infrastructure platform remains in a validated or qualified state (fit for intended use) per Roche policies and procedures. This document applies t

This Standard Operating Procedure (SOP) applies to the following: - Organizational scope: All Roche Informatics functions, all Roche business functions and individuals acting on behalf of / or as partners with Roche Informatics (e.g.

The aim of this document is to describe the global mandatory Informatics Training Management process to the process performers, their roles and their interactions with other roles within the process. The process described in this document applies to global Informatics (Ix) mandatory training.

This Standard Operating Procedure (SOP) describes the required activities for assessing vendors of computerized systems and services in order to determine their ability to supply systems, services or software of high quality and suitable to support GxP regulatory requirements. The assessment should

and Objectives The aim of this document is to provide the necessary and sufficient level of detail to describe the Change Management process. It ensures that process performers understand their roles and their interactions with other roles within the process. This Change Management process applies t

The purpose of the RDT Deviation and CAPA Management process is to provide a systematic approach to identifying, reporting, investigating, documenting, correcting, and preventing deviations from approved GxP regulatory relevant RDT QMS processes or procedures (and associated Policies, Directives, SO

The key purpose of this Document Standards SOP is to: - Define Document Standards for RDT owned documents. - Outline document types used in RDT. RDT must follow this SOP for documents owned by RDT on these organizational scope levels: 1.

This SOP provides the necessary and sufficient level of detail to describe the Service Configuration Management Process to the process performers, to understand their role, accountabilities, and interactions with other roles within the process. This SOP is complemented with several Service Configura