Processes: System Lifecycle Management

End-to-end process for authorizing and executing a product release to the Production Environment as described in SRD-0145688. Spans completion of all release-level Definition of Done criteria, creation and approval of the Release Summary, and raising of a Change Control record to authorize deploymen

Repeatable iterative sprint cycle for GxP computerized system delivery as defined in SRD-0145688. Covers selection of sprint backlog items, design and build of user stories, testing against acceptance criteria, defect management, and verification of the Definition of Done for the Product Increment b

Describes the controlled shutdown of a withdrawn computerized system as defined in sop031555. The System Owner is accountable for ensuring decommissioning activities are defined, executed, and documented, with the CS removed from the active inventory and configuration management updated to reflect t

Defines the step-by-step procedure for creating, maintaining, and retiring Computerised System records (Business Applications) in ServiceNow APM, as specified in WI-0301164. Covers the full lifecycle from initial registration through compliance data population to retirement, with specific role assig

Defines the scope, strategy, change control, and risk assessment for retiring a computerized system as described in sop031555. The Process Owner is accountable for ensuring all retirement activities are planned, documented, and approved before commencement of any retirement activities.

Process for identifying, developing, and delivering training required before a computerized system is released for GxP use. Covers both business end-user and IT support personnel training. Defined in sop031553 section 7.2.

Describes the process of removing a computerized system from active end-user operations as defined in sop031555. The Process Owner is accountable for defining and executing withdrawal activities, including account deactivation, interface disabling, and communication, with results documented in a Wit

Defines the review and approval lifecycle for CSV deliverables (URS, FS, DS, Test Plans, Release) within the ASPIRE-SOLMAN Focused Build methodology in SAP Solution Manager. Specifies role accountabilities (QA, Validation Lead, Business Analyst, Process Owner, Test Coordinator, Test Engineer, Soluti

End-to-end process for implementing and validating a GxP computerized system, covering validation approach definition through release to production and inventory registration. Defined in sop031553 sections 10.1 through 10.16, supporting waterfall, agile, and hybrid delivery methodologies.

The CSV Periodic Review process defined in SOP-0107426 verifies whether GxP computerized systems and IT Infrastructure platforms remain in a validated or qualified state. It covers planning and scheduling, executing structured verification checks across defined areas, reporting results in a formal r

Covers the controlled process of moving regulated data from an operational computerized system to a long-term repository as defined in sop031555. The Process Owner is accountable for ensuring archived data is accessible, retrievable in human-readable format, and integrity-maintained throughout the r

Defines the procedure for processing Data Certification Tasks in ServiceNow to periodically verify and validate the accuracy of Business Application compliance data, as described in WI-0301164. Certifiers receive task notifications, review and correct Business Application fields, and formally attest

Process for migrating data between computerized systems, covering planning, risk assessment, tool qualification, execution, verification, and reporting. Initiated as part of an implementation project or via change management. Defined in sop031553 Appendix C.

Maintains IT infrastructure components, solutions, and platforms in a qualified state during productive use. Covers technical maintenance, IaC code migration, and periodic review activities as defined in SOP-0303080.

Implements the qualification lifecycle for IT infrastructure components, solutions, and platforms supporting GxP processes. Covers planning through deployment with tailored approaches for manual and IaC delivery methods as defined in SOP-0303080.

Retires IT infrastructure components, solutions, and platforms through controlled data archival, decommissioning, and disposal activities triggered through change management as defined in SOP-0303080.

This process (WI-0300929) defines the end-to-end execution of Periodic Reviews for GxP-relevant Computerised Systems using ServiceNow IRM Engagements. It covers planning, fieldwork (control testing), issue creation, approval, and closure, with automated steps triggered by the CS Inventory master dat

Ensures regular backup of CS software, configuration, and operational data with periodic log review and restoration testing to guarantee data recovery capability. System Owner is accountable for the entire backup and restore process per SOP-0109167.