Processes: Quality Management System

The CSV Change Advisory Board assesses internal improvement proposals and external regulatory changes, then the Change Coordination Board selects proposals for implementation and creates a detailed release plan with resource estimates. Defined in document 10201920 as activities A1 and A2 of the CSV

During CSV release maintenance mode, the CSV Process Owner Team maintains formal feedback channels, manages incoming feedback from all employees, provides formal responses, and feeds improvement opportunities back into the improvement proposals list. Defined in document 10201920 as activity A5 of th

Following release approval, the CSV Process Owner Team sends targeted communications to all employees about the new release and coordinates training needs identification and fulfillment before the release becomes effective. Defined in document 10201920 as activity A4 of the CSV Governance Model.

CSV Approvers formally review new CSV release documentation, verify organizational readiness against the implementation plan, and provide formal approval or feedback for escalation. Defined in document 10201920 as activity A3 of the CSV Governance Model.

A structured GxP compliance assessment workflow defined in SRD-0139481 for identifying data integrity risks and gaps across data, systems, and processes. The assessment evaluates adherence to ALCOA++ principles for computerized systems, procedures, and quality systems, resulting in documented correc

Coordinated process for supporting Health Authority inspections of GxP computerised systems, covering preparation, during-inspection activities, and post-inspection follow-up between Contract Giver (PT) and Contract Acceptor (IT). Defined in AGR-0304935 with specific notification timelines and respo

A structured review process defined in SOP-0302802 that monitors and evaluates key IT processes against defined metrics and objectives. The process covers two levels — Quality Oversight and Process Owner — and follows a mandatory eight-step lifecycle from scope definition to final reporting.

A structured periodic review process defined in POL-0300118 for evaluating the health and effectiveness of the IT QMS across Roche Informatics. The process combines Quality Oversight reviews, Process Owner reviews, data integrity validation, compliance assessment, and management review to ensure adh