Roles: Cross-domain

Any Roche user accountable for compliance with password requirements, proper handling of their credentials, and immediate password change upon suspected compromise. Responsible for all actions performed under their user identification.

Ensures GenAI performance thresholds align with the Context of Use, provides input for testing set collection to ensure accuracy and relevance to intended use, and defines update cadence for RAG knowledge bases. Accountable for business requirements alignment throughout GenAI validation lifecycle.

For internally implemented and managed Computerized Systems, ensures all internal and external personnel are formally qualified before performing tasks, maintains ongoing training for IT technical personnel when technologies change, and retains training records. Formalizes training gap assessment an

Line or functional manager accountable for ensuring proper CSV training of their employees, ensuring employee compliance with the Roche CSV process, and escalating identified CSV issues to the CSV Process Owner.

Any employee who applies the CSV process in daily work, including operational support units, validation teams, audit units, project managers, and business process owners. Accountable for reading CSV communications, following CSV in daily work, and escalating issues to line managers and the CSV Proce

Accountable for ownership and continuous improvement of the full CSV Framework, supports CSV across the organization, assesses all feedback received, participates in CAB and CCB, and serves as the escalation and final decision point for governance issues. Organizationally held by IT QA (Informatics

Provides formal authorization for changes at both the Authorize Change phase and Authorize Change Implementation phase. At minimum includes the Service Owner; expanded for GxP-relevant services to include Business Process Owner and QA representatives. Cannot be the same person as the Change Requeste

Approves L1 Policy documents as the senior executive accountable for digital and technology governance. For Roche Group-wide policies acts together with relevant CEC members.

Accountable for the integrity and compliance of specific data at various stages of the data life cycle and for data archiving. Assesses equipment, systems, and related process designs against Data Integrity requirements. Defines with technical personnel appropriate controls to secure records and red

Owns the Installation Verification document and provides formal approval as part of the document approval workflow for standard changes.

An SME — such as a Practice/Process Owner, System Owner, Validation Lead, Compliance Officer, or Product Manager — who detects and reports a potential deviation from approved processes, procedures, or standards. Responsible for creating the initial IT Deviation record and describing all known facts.

Subject Matter Expert in Digital Compliance who is required to support the Assessor during assessment execution when the vendor provides AI technologies, ensuring AI-specific compliance requirements are addressed in the evaluation of vendor documentation.

Accountable for the complete document lifecycle including setting periodic review intervals, managing effective and withdrawal dates, and ensuring documents remain current and compliant with GDP standards. Approves documents and decides on document retirement.

Authors and maintains GxP data integrity policies and standards, ensuring alignment with applicable health authority regulations and guidance as defined in GOV-010156.

Accountable that organizations within their area of quality oversight (Pharma Product Development, Pharma Technical Operations, Diagnostics, Informatics) have the structures, processes, and resources to implement and ensure compliance with the GxP Data Integrity Policy (GOV-010156).

Policy owner for the Roche GxP Data Integrity Policy (GOV-010156), accountable for maintaining global data integrity governance and records management standards across Roche.

Document owner responsible for the Vendor Quality Assessment Questionnaire template (GD-0304336). Provides final approval for VQA supporting documents and oversees the IT quality assurance function governing GxP computerized system vendor assessments.

Reviews L1 Policy and L2 Directive documents for RDT-scoped documents, providing governance oversight of the document hierarchy.

IT leaders below the Senior Management level who lead by example in implementing the IT QMS, define and communicate regulated roles and responsibilities, promote a quality culture with quality-by-design principles, and ensure all staff are aligned with quality objectives throughout the Informatics o

Approves GxP data integrity policies, providing quality assurance oversight for IT systems and data integrity requirements as defined in GOV-010156.

IT-level quality assurance reviewer responsible for reviewing and approving the Vendor Quality Assessment Questionnaire (GD-0304336). Ensures the questionnaire content meets IT quality standards and regulatory compliance expectations for GxP computerized system vendors.

Management-level role responsible for approving vendor quality assessment documentation (GD-0304336). Provides management sign-off ensuring alignment of VQA materials with IT risk, audit, and compliance requirements.

Accountable at the executive level for the IT QMS, ensuring the Roche Quality Policy is followed and overall IT quality strategy and objectives are established, communicated, and supported. Responsible for resource allocation, conducting regular Management Reviews, and defining improvement actions t

Holds overall accountability for Informatics training strategy, aligning it with Ix objectives and capability development. Supports organization-wide training requirements (legal, security, regulatory, compliance) and reviews key monitoring metrics aligned with training objectives.

Cross-functional committee responsible for oversight of the global mandatory training catalogue in Informatics. Reviews new requests for global mandatory training to ensure the catalogue is kept current and relevant across all Informatics personnel categories.

Pharma Technical Computerized Systems quality assurance representative responsible for reviewing vendor quality assessment documentation (GD-0304336). Provides quality approval from the Pharma Technical Operations perspective ensuring vendor assessments support GxP-compliant operations.

Approves the User Requirements Specification (URS) and confirms completed functional Test Plans regardless of GxP or ICFR relevancy. Participates in Work Package management per SolMan ALM Solution Documentation. May be represented by a formal deputy.

Responsible for creating the Product Delivery Strategy and Product Backlog. Involved in drafting AI-related User Stories, approving AI model development documentation, and identifying business supporting procedures.

Accountable for entering and maintaining compliance-related attributes — particularly GxP relevance information — on Service CI Records in the CMDB, in coordination with the Service Owner.

For GxP systems, consults on and approves the risk-based test strategy as part of governing documents such as the Validation Plan or Product Delivery Strategy; approves test artifacts applying the 4-eyes principle.

Reviews and approves CSV deliverables for GxP computerized systems in SOLMAN. Provides Release approval covering test plans and unresolved defects. Retrospectively reviews Urgent ChaRMs for GxP-relevant changes. BQA covers Business systems; ITQA covers IT4IT systems. QA role may not be delegated.

Mandatory additional role for GxP service problems; contributes to assessments throughout the problem lifecycle, ensures problems with GxP impact to patient safety, product quality, or data integrity are captured in the relevant Quality Management system (e.g., CAPA or Event records), and ratifies r

Organizational function responsible for establishing and maintaining the Document Management Governance Framework within RDT. Centrally controls Policies, Directives, SOPs, and related Supporting Documents that apply to all of RDT.

Final approvers and accountability holders for GxP-regulated activities executed in their respective area. Ultimately accountable for ensuring all medicinal products are distributed in a safe and compliant manner, including relying on data from validated systems used in warehousing and logistics.

Assesses quality of GenAI sub-system outputs using defined evaluation scales and criteria. Must possess necessary understanding of the outputs and be trained on testing procedures. Should not be part of the product delivery team to minimize conflict of interest and bias. Number of evaluators should

Reviews documents at all hierarchy levels to ensure technical accuracy and subject matter coverage. For L1/L2 documents may be a member of the owner's Leadership Team or Business Operations; for L3 documents is a Practice Owner representative or Business Operations nominee.

Subject matter experts from functions such as IT Security, Legal, and Audit who provide assessments and recommendations on potential risks from their respective areas of responsibility to support the Process Owner.

Oversees the Agile process, provides feedback, and mentors the Development Team and Product Owner in GxP Agile delivery per SRD-0145688. Ensures Agile ceremonies of Definition of Done and Definition of Ready are executed as defined in the Product Delivery Strategy, coaches the team in self-organizat

Chapter lead of the organizational unit (SQC) responsible for overall IT QMS quality management. Provides the Informatics quality framework, designs and optimizes the Operating Model for IT/Ix, runs periodic management reviews, and ensures built-in quality and compliance across all Informatics funct

Ultimately responsible for the availability, support and maintenance of the AI sub-system, and the quality and security of the data used by and/or residing on the sub-system. Cannot be combined with Quality Assurance but may be combined with System Owner or Process Owner.

Acts as single point of contact (SPOC) for each process area category in scope of the Computerised System Glossary. Reviews and confirms the validity of nominated terms (new, updated, or withdrawn) related to their specific process areas.

Accountable for availability, support, and maintenance of the computerised system and security of data residing on it. Responsible for delivering, supporting, maintaining, and retiring computerised systems throughout the lifecycle. Ensures secure operation, adequate maintenance, compliance with regu

A cross-functional team convened to assess the potential impact and risk classification of a deviation, composed of the Deviation Initiator, Deviation Owner, and applicable Quality Assurance representative. May also include the RDT Process/Practice Owner of the affected process and business represen

Provides post-execution approval of standard changes in validated environments, reviewing the completed Installation Verification document and signing off in the Deployment Signature Log.