Artifacts: Documentation & Records

Documented outcome of the annual review of personnel qualification and training status against training requirements (TM04). Must capture any deviations from training requirements.

A form of metadata defined in SRD-0139481 that provides tracking information about lifecycle events related to the creation, modification, or deletion of GxP data, without obscuring or overwriting the original data. Audit trails must be retained with the data they describe, reviewed regularly based

Centralized glossary of standardized terms and definitions used across Roche Informatics in global policies, directives, SOPs, and instructions. Published on the myCSV gsite and maintained through a formal change process with EDMS approval.

Level 2 RDT document issued as an executive mandate defining at a high level WHAT must be followed by the organization. Covers broad areas affecting a large number of employees and is elaborated in multiple SOPs and Instructions. Must be released in Veeva QualityDocs.

Defines the required reviewers and approvers for each document type within Informatics. Specifies approval authority levels and review requirements for different document categories to ensure proper governance of the documentation lifecycle.

A validated process output defined in SRD-0139481 that identifies and documents predetermined abnormal data or actions requiring further attention or investigation, applicable as an alternative to routine audit trail review. Exception reports must be generated through a validated process and reviewe

Owned and maintained by Quality Assurance, this catalogue contains the training matrix of global mandatory training applicable to Ix employees and external partners, along with templates and forms used as attendance sheets, self-reading, and other training evidence.

A catalogue listing all mandatory training courses assigned to Informatics personnel including internal staff, contractors, consultants, and managed service providers. Training completion is required within 60 days of assignment.

Level 4 RDT document elaborating on one or more activities of an SOP with detailed sequential steps, tailoring options, input-output specifications, and associated responsibilities and measurements. May have variants for different situations. Must be released in an EDMS.

A documented piece of organizational knowledge captured to improve the efficiency of service management processes such as Incident and Request Management by reducing the need to rediscover known solutions.

Level 1 RDT document declaring senior management's intention and commitment (the WHY) for certain objectives. Non-negotiable, enabling fast decision-making and ensuring compliance with laws, regulations, and corporate principles. Must be released in Veeva QualityDocs.

L1-level organizational policy (POL) that defines the 'why' for a domain area. Requires review by SME Representatives and the Head of Strategy, Portfolio & Governance, and approval by the Document Owner (Policy Owner from RDT LT) and Chief Digital and Technology Officer.

Level 3 RDT document providing a detailed step-by-step description of HOW to execute a process consistently. Includes process roles, entry and exit criteria, and sequential or modular activities. Must be released in an EDMS (recommended: Veeva QualityDocs).

Supplementary RDT document providing additional information about its governing document (Policy, Directive, SOP, Instruction, TOP, or LCD). May describe recommended activities, guidelines, approaches, techniques, templates, or datasets. Released in the same EDMS as the governing document.

Document issued by RDT Functions describing activities to be followed to consistently accomplish a particular task, operation, or procedure related to a specific RDT Function, technology, or system. Produced and managed by teams for day-to-day operational guidance, used globally or locally.

Inventory of courses 'to do' resulting from comparing an individual's current training status against the mandatory training needs associated with their position and roles. Produced during TM02 Training Needs Assessment and Planning.

Controlled list of training sessions attended by the trainee, maintained in the global ELMS (Cornerstone) or approved repositories. Captures the history of all training completed.

List of global mandatory Informatics training and skills required for each function/position, maintained in the global ELMS. May include a standard part common to all functions and a specific part for particular groups. Maintained by IT QA for the global matrix and by each department for area-specif

Supporting documentation resulting from training gap assessment, describing the to-do list for fulfilling mandatory Informatics training. Managed in global ELMS (Cornerstone). Does not require formal approval.

Records documenting completed training for end-users and IT technical personnel, including qualification evidence and verification of external personnel training for each computerized system access profile or role.

A verified copy of an original GxP record defined in SRD-0139481, created for review, backup, or archival purposes, with the same complete information as the original including metadata and audit trail. True copies may be retained in a different file format from the original if the full meaning and