Artifacts: Change & Configuration Management

New entry in the Allow List object for Admin Change ChaRMs in SOLMAN. Reviewed by Validation Lead/Unit (CSV) for Non-GxP Admin Changes only. Validation Lead verifies evidence and provides approval or rejection comments in the text section.

A documented set of procedures required to revert a configuration or service to its previous stable state in the event of a failed implementation. Also referred to as a Fallback Plan. Created and tested during the Schedule Change phase before implementation is authorized.

A SQL script generated during the installation execution that captures server output and can be used to reverse the change if verification fails. Uploaded to Project Library as part of the change evidence package.

The authoritative representation of a Configuration Item in the CMDB (ServiceNow), capturing all attributes, relationships, lifecycle status, and compliance information required to manage and control the CI throughout its operational lifecycle.

Regular reports generated from the Configuration Management Database (ServiceNow) used by Service Owners to monitor CI Record accuracy, attribute completeness, relationship integrity, and process adherence across the CI portfolio.

Records CSV and QA review status for Change Request Management (ChaRM) objects in SOLMAN. The CSV/QA Review Status field captures review progression for Normal and Urgent changes. For Admin Changes, review comments and approval decisions are captured in the text section.

Approved record documenting the risk characterization of a change to an operational computerised system, covering impacts on patient safety, regulatory compliance, business processes, product quality, data integrity, technology, and security controls.

A formal record documenting a requested change to IT services or systems, capturing evaluation, approval, planning, testing, implementation, and post-implementation review in a controlled manner.

One or more normal change requests created to manage retirement activities through the established change management process. May cover withdrawal, data archival, and decommissioning separately or as a single request, approved by Process Owner and respective QA unit.

A documented plan produced during the Verification and Audit process to reconcile discrepancies found between the CI inventory and CI Records in the CMDB, agreed with the requestor of the verification.

A point-in-time inventory of Configuration Items used during Verification and Audit activities to check conformity with CI Records in the CMDB, identifying discrepancies in ownership information, count, and content accuracy.

Updated records identifying the current configuration of a computerized system and its related components, maintained following any change or maintenance activity.

A database of Configuration Items (CIs) capturing accurate information about components and services in the IT landscape, used to support IT decision-making and other ITSM processes.

Documentation of an Emergency Change capturing all required information for audit trail completeness. May be created retrospectively after service restoration but must be completed promptly after the emergency is resolved.

The controlled execution record for a standard change, capturing environment details, pre-requisite completion, installation step results, verification outcomes, rollback readiness, and multi-role sign-off.

A formal review conducted after change implementation to verify that change objectives were met and to identify lessons learned. Conducted by the Change Manager with key stakeholders. For GxP-relevant changes, covers post-execution documentation such as execution logs and test results.

Release cycle object in SOLMAN grouping changes for deployment. QA adds a release approval note in the Release audit trail covering test plan and unresolved defects before deployment. For IT4IT systems, Validation Lead creates a Release summary via CSV notes or attachment when no approved test repor

The formal record initiating the change management process, submitted by the Change Requester. Contains all mandatory information required to assess and process the change request, including change details, impacted services, proposed implementation date, and change type classification.

A formal proposal to establish a new Standard Change template, based on a successfully completed Normal Change that proves the procedure is repeatable and documented. Must be approved by the Service Owner and, for GxP-relevant services, also by BPO and QA unit representative before activation.