Artifacts: Quality Management System

Written report provided to Contract Acceptor after completion of an audit, documenting all findings from on-site audits of computerised systems and projects. Contract Acceptor must provide formal written response within 28 calendar days.

Approved report documenting the review of data and system audit trails for a computerized system, with findings and any corrective actions identified, produced at a frequency determined by system risk and complexity.

A formal plan ensuring the Informatics organization can maintain essential functions and recover swiftly in the event of disruption or disaster. Must be regularly tested, updated, and reviewed to address evolving risks and maintain operational resilience.

Detailed plan created by the CCB and CSV Release Manager defining all documentation and organizational changes needed for a new CSV release, including schedule milestones, effort estimates per affected area, and training and communication timelines.

An assessment deliverable described in SRD-0139481 that captures data integrity risks, ALCOA++ compliance gaps, and corrective and preventive actions across GxP-relevant data, systems, and processes. The report is produced as the output of the Data Integrity Assessment process.

Document created and maintained by PD Quality Assurance to provide transparency on quality assurance work completed for data integrity across RDT systems and processes. Provides assurance to health authorities and internal stakeholders that data integrity, product quality, and patient safety have be

A curated version of the Final Report intended for broader distribution that excludes confidential information. Reviewed by the Review Owner and stored in a designated document repository. May be shared with external stakeholders such as auditors or inspectors with prior approval from the Global IT

A global governance policy establishing Roche's requirements for data integrity across all GxP-relevant data throughout its lifecycle, applicable to all Roche legal entities and service providers.

The foundational policy document defining the elements of the Roche Informatics IT Quality Management System (IT QMS). Establishes QMS principles, components, governance structures, and management responsibilities for all Roche Informatics functions and service providers acting on their behalf.

A plan defining procedures and responsibilities to maintain or restore Informatics operations during and after a disruptive event, covering continuity and disaster recovery scenarios.

Compiled collection of evidence gathered by Contract Acceptor to support a health authority inspection or external audit, uploaded to the inspection gDrive following the defined inspection process. Subject to quality control review by Contract Giver before submission to auditors.

A running register maintained by the CSV Process Owner of all internal improvement proposals, suggestions, complaints, and feedback received from employees and audit findings, used as primary input to CAB assessment meetings.

Output of CSV CAB assessment meetings; a prioritized and justified list of proposals accepted for implementation in upcoming CSV releases, including technical and organizational impact assessments and criticality ratings.

Detailed record of each review meeting capturing all discussions, decisions, action items, and follow-up activities. Quality Oversight meeting minutes require formal approval by the Review Owner; Process Owner meeting minutes do not require formal approval but must be available as input to Quality O

Formal agreement between Contract Giver (PT) and Contract Acceptor (IT) defining roles, responsibilities, and quality oversight requirements for GxP computerised systems. Must be reviewed for accuracy and compliance at least once every three years.

Formal agreement between Contract Giver (PD) and Contract Acceptor (RDT) establishing quality and compliance responsibilities for GxP computerised systems. Must be reviewed for accuracy and regulatory compliance at least every three years, with changes requiring mutual written consent and documented

Assessment determining the impact of a deviation or change on product quality, patient safety, regulatory compliance, data integrity, and validation. Required for all significant deviations and major changes.

A periodic report produced during the Quality Management Review process documenting the health of the IT QMS, compliance status, audit results, CAPA outcomes, and improvement actions. Used by the IT QMS Governance Board to make evidence-based decisions and maintain the right to operate.

A comprehensive planning document developed and integrated into the QMS to systematically address all aspects of quality throughout the IT system product lifecycle. Governed by IT Senior Leadership as part of the overall Ix strategy to align and promote the Informatics strategy.

A formalized document outlining the approach, criteria, schedule, and procedures for conducting self inspections. Ensures reviews are systematic, consistent, and thorough. Quality Oversight Review Plan is approved by the Global IT Quality Assurance Lead; Process Owner Review Plan is approved by the

The official record of the self inspection review process compiled by the Quality Oversight Team upon completion of the review. Provides a basis for future improvements and compliance verification. Distributed to IT QMS Governance Board within two weeks of approval.