Processes: Change & Configuration Management

Defines Quality Assurance and CSV/Validation Unit involvement during ChaRM (Change Request Management) workflow in SAP Solution Manager for Normal, Admin, and Urgent change types. Specifies review sequence and status transitions for GxP and non-GxP relevant changes. Urgent changes require retrospect

Governs the request, assessment, approval, and implementation of changes and enhancements to validated computerized systems, including supplier-initiated and infrastructure changes. Ensures the validated state of the system is maintained and configuration items are updated per SOP-0109167.

Determines control mechanisms for updating CI Records as changes occur over the Configuration Item lifecycle, including creation, maintenance, relationship updates, and retirement. Defined in SOP-0303612 with compliance rules for GxP-relevant services.

Determines the scope and selection criteria for Configuration Items to be created in the CMDB as CI Records, ensuring they are manageable and traceable throughout their lifecycle. Defined in SOP-0303612, this process covers planning, creation, relationship configuration, and activation of CI Records

Determines CI Record traceability over the Configuration Item lifecycle by analyzing CMDB reports, identifying required updates, and executing corrective actions. Defined in SOP-0303612, this process ensures CI Record ownership, status, attributes, and relationships remain accurate.

Determines conformity between Configuration Items and CI Records when a verification request is received, reconciling any discrepancy between the CI inventory and the CMDB. Defined in SOP-0303612, it covers verification analysis, action planning, and remediation execution.

An expedited change management process defined in SOP-0304218 for immediate action required to resolve Major Incidents or issues threatening product quality, patient safety, or data integrity. Steps may be performed retrospectively to allow immediate service restoration, but all documentation must b

A controlled procedure for executing, verifying, and signing off a standard change to a validated system (doc 18470290). Covers pre-requisite checks, database-level installation steps, post-installation verification, rollback readiness, and multi-role sign-off in a GxP-compliant deployment workflow.

The full change management lifecycle for Normal Changes as defined in SOP-0304218. Covers creation, assessment, authorization, build/test scheduling, implementation authorization, execution, and post-implementation review and closure of changes to services and infrastructure. Ensures all changes are

A streamlined change management process defined in SOP-0304218 for changes with clearly defined scope and proven repeatable procedures established via approved templates. Standard Pre-Authorized changes proceed directly to implementation; Standard With Authorization changes include build/test coordi