Artifacts: System Lifecycle Management

A document capturing a significant architectural decision made during solution design, including context, options considered, decision rationale, and consequences. Produced by Solution Architecture as part of CSV lifecycle.

Documents the high-level design of the IT infrastructure architecture and its interdependencies with other components. Updated during delivery and after testing as needed.

A procedure or control document included in process R&R documentation that defines intervals and responsibilities for periodic review of archived data availability, integrity, and eventual deletion at end of the retention period.

Execution logs recording the completion and status of CS software, configuration, and operational data backups, reviewed periodically to ensure data availability and used to identify errors requiring incident reporting.

A plan defining the scope, approach, acceptance criteria, and access controls for archiving regulated data from a retired computerized system to a long-term repository. May be included within the CS Retirement Plan.

An approved report summarizing the results of data archival activities, confirming data integrity, accessibility, and retrievability, and documenting any issues encountered. May be included within the CS Retirement Report.

A plan defining activities for the controlled shutdown of a withdrawn computerized system, including account deactivation, agreement management, software license discontinuation, and hardware/software redeployment or disposal. May be included within the CS Retirement Plan.

An approved report summarizing decommissioning activities and results, identifying deviations from the approved plan and issues encountered during decommissioning. May be included within the CS Retirement Report.

The comprehensive plan for retiring a computerized system, covering retirement strategy, scope definition, open items, retention requirements, and optionally encompassing withdrawal, data archival, and decommissioning sub-plans. Approved by Process Owner and QA unit.

A plan defining activities for removing a computerized system from active end-user operations, covering permission changes, SLA continuity, interface disabling, stakeholder communication, and periodic review requirements during withdrawal. May be included within the CS Retirement Plan.

An approved report summarizing the results of CS withdrawal execution, identifying deviations from the original withdrawal plan and any remaining unresolved issues. May be included within the CS Retirement Report.

A CSV artifact owned by the CSV Process Owner that maintains a current inventory of all validated computerized systems, their validation status, and key lifecycle dates to support ongoing compliance monitoring.

Documents system configuration settings in SOLMAN as Configuration Guide. Created by Solution Architect, reviewed by Validation Lead, approved by Business Analyst. Exceptions: CSV review not required for MDG CG (Data Models), Authorization CG, and Soft-Configuration.

Documents software configuration settings to meet requirements and specifications, associated with specific software or system versions. Includes infrastructure configuration settings and vendor-specific customer configurations.

A ServiceNow IRM object created automatically when the Engagement advances to Fieldwork, representing a specific control to be evaluated. Contains Design Test and Operation Test sub-tests with result justifications and an Effectiveness determination. Defined in WI-0300929.

Documents how infrastructure-related data, audit trails, and IaC qualified code (including previous versions) are archived according to applicable retention periods during retirement.

Summarizes executed data archival activities including verification that archived data and code are accessible and properly maintained in the long-term repository.

A ServiceNow task generated by an active certification schedule that prompts the certifier to periodically review and formally attest to the accuracy of Business Application compliance data.

Documents how IaC qualified code packages are migrated to a target system, including migration procedures and testing approach to verify the package works as expected at the target.

Summarizes executed IaC code and documentation migration activities including verification results. Approved after successful migration and testing at the target system.

Documents the procedure for shutting down an IT infrastructure platform in a controlled manner, including configuration management system updates and change management steps.

Summarizes executed decommissioning activities for an IT infrastructure platform, confirming proper shutdown and configuration management system updates.

Records system defects identified during test execution in SOLMAN. For GxP and ICFR relevant systems, all defects are reviewed by Validation Lead before the Test Plan is set to Completed. Lifecycle: New→In progress→Solution Proposal→Confirmed with parallel Defect Correction objects.

A tracked record of a defect identified during testing or operations, capturing its origin, severity, status, and resolution, including association with related requirements and problems.

Documents technical design for the computerized system in SOLMAN as DS Documents. Created by Developer with Developer Lead 4-eyes principle. Reviewed and approved by Validation Lead. Lifecycle: Draft→Ready for Review→Ready for Approval→Approved.

Technical implementation details for each functional component including relationships between components, hardware and software design, and integration criteria. Required for internal development, COTS customization, and specific configurations.

Plan defining recovery procedures and testing schedules for restoring a computerized system following a major disaster event, including roles of external vendors and contracts defining their participation.

A standardized set of harmonized, S.M.A.R.T. functional and non-functional requirements ensuring a computerized system complies with FDA 21 CFR Part 11 and EU GMP Annex 11. Requirements are copied directly into the system Requirements Specifications or User Stories.

A formal inventory documenting all GxP-relevant Electronic Records created, modified, maintained, archived, retrieved, or transmitted by a computerized system. Produced during the define stage of the implementation phase and included in the Technical Assessment.

A formal inventory documenting all Electronic Signatures required by GxP processes, each linked to the specific Electronic Record it covers. Produced alongside the ER Inventory during the define stage of system implementation.

Documents functional design of the computerized system in SOLMAN as FS Documents. Created by Solution Architect, reviewed by Validation Lead, and approved by Business Analyst. Lifecycle: Draft→Ready for Review→Ready for Approval→Approved.

Describes the functions the computerized system must have to satisfy requirements, including business process functions, data handling, and security controls. Must be verifiable and traceable to requirements.

Comprehensive and up-to-date inventory of all PD GxP computerised systems owned and maintained by the Contract Acceptor (RDT), managed in the RDT Configuration Management Application. Contract Giver must have adequate access to facilitate oversight responsibilities. System Owner, Process Owner, and

A ServiceNow IRM object automatically created for each Control Test where at least one sub-test is Ineffective. Represents an IT Deviation requiring corrective action and is managed according to the RDT Deviation and CAPA Management process (WI-0303360). Referenced in WI-0300929.

Documents the qualification of underlying hardware and infrastructure components for development, test, and production environments following approved qualification procedures.

Details the installation, configuration, and operational checks for IT infrastructure platform qualification through manual delivery. Verifies completion and confirmation of configuration and installation.

A ServiceNow APM localization record linked to a parent Business Application, representing a scope-specific instance of the Computerised System with dedicated local ownership and QA oversight assignments.

Documents maintenance support activities, procedures, and support organization required to maintain the IT infrastructure platform. Includes vendor SLAs when external vendors provide ongoing support.

Records and reports documenting monitoring of CS performance, availability, and supporting infrastructure metrics, including SLA fulfillment reporting from service suppliers.

The central ServiceNow IRM object used to manage and document a Periodic Review of a GxP Computerised System. Automatically created 90 days before the next review initiation date and progresses through states: Validate and Plan, Fieldwork, Awaiting Approval, Follow Up, and Closed. Defined in WI-0300

A CSV artifact owned by the CSV Process Owner providing a structured template for conducting and formally documenting periodic reviews of validated computerized systems to confirm continued compliance.

A PDF report showing the full contents of an approved Periodic Review Engagement. Can be generated ad-hoc via the 'Generate PDF' button when the Engagement is in Follow-up state, or is automatically generated and attached when the Engagement is closed. Defined in WI-0300929 Section 5.2.

A formal report created by the System Owner and approved by the Process Owner and Quality Assurance that documents the results of a CSV Periodic Review, confirming whether the computerized system or IT Infrastructure platform has been maintained in a validated or qualified state or identifying requi

A schedule maintained by Quality Assurance tracking Periodic Review Initiation Dates and Due Dates for all GxP validated computerized systems and IT Infrastructure platforms, with review intervals determined by regulatory impact classification.

The sum of all Product Backlog items completed during one or more sprints, presented to stakeholders at sprint end as defined in SRD-0145688. Considered complete only when the Definition of Done for the Product Increment is fully achieved. Could potentially be released for business use.

High-level plan of how a GxP product will evolve over time, developed in consultation with Business, IT, and Quality Stakeholders and maintained on a regular basis as defined in SRD-0145688. Contains both short-term and long-term views of future product functionality and when new features will be re

Documents the scope, roles and responsibilities, strategy, prerequisites, activity sequencing, and acceptance criteria for IT infrastructure platform qualification efforts. Addresses SRA and data classification outcomes.

Details the installation, configuration, and operational checks for IT infrastructure component or solution qualification through manual delivery. May embed detailed requirements for individual components/solutions.

Identifies all lifecycle documentation and maintenance procedures that support the qualified status of the IT infrastructure platform. Can be part of the Qualification Summary Report or an independent document.

Summarizes the results of all IT infrastructure platform qualification activities and associated documentation. Includes a clear statement that the platform is qualified as per original intended use.

Documents the intended use of the computerized system and all requirements including business process, regulatory, security, data integrity, and technical requirements. Each requirement must be uniquely identified and meet SMART criteria.

Test Script in SOLMAN documenting individual test cases for System Acceptance Testing or User Acceptance Testing. Created and approved by Test Engineer with 4-eyes principle. Reviewed by Validation Lead by sampling during Work Package review.

Subset of the Product Backlog selected for execution during a specific sprint as defined in SRD-0145688. Defines the tasks to be completed to deliver the user stories planned for the sprint and is managed within IT Tools.

A current documentation artifact required by SRD-0139481 for each GxP computerized system, detailing system components and interfaces to identify data flows between systems and processes. This document must be kept current and forms part of the system's validated state documentation.

Document created as an outcome of implementation, maintenance, or retirement activities of a system that resides with the system throughout its full lifecycle. Classified as Dynamic (kept current, e.g., IV protocol, System Specifications, OSP, Test Cases) or Static/Historical (point-in-time, e.g., V

Planning document governing the retirement of a computerised system. May incorporate the retirement risk assessment if not documented separately; must be approved only after the retirement risk assessment is complete.

Defines the specific technical needs and behavior for an IT infrastructure component, solution, or platform including installation, configuration, operational, regulatory, and security requirements.

A predefined test artifact containing test inputs, execution conditions, and expected results developed to verify compliance with specific computerised system requirements, requiring 4-eyes approval before execution.

Structured test scenarios defining inputs, execution conditions, and expected results to validate that a computerized system meets its specifications and regulatory requirements.

Documents the test approach, scope, and test cases for SAT/UAT in SOLMAN. Managed through two phases: pre-execution (Created→Ready for Approval→Approved for Execution→Released for Execution) and post-execution (Released for Execution→Completed, confirmed by Process Owner).

Defines the test scope, prerequisites, test strategy, acceptance criteria, and defect handling approach for IT infrastructure platform qualification testing.

A record generated during test execution providing documented evidence that testing activities were performed to verify a computerised system requirement or functionality, requiring 4-eyes approval.

Documented outcomes of executed test cases, capturing actual results against expected results, defects identified, and overall test execution status for GxP-regulated system validation.

Records the execution of SAT/UAT Test Cases in SOLMAN. Test Coordinator/Engineer creates, executes, and closes the test run. Validation Lead reviews by sampling before approving Test Plans as Completed.

A document defining how testing will ensure requirements and specifications of a computerised system are met, established before starting testing activities, and approved by QA for GxP systems.

A report created at the end of the acceptance testing phase providing a consolidated view of performed test and verification activities to demonstrate suitability for releasing the computerised system.

Summarizes all test results, deviations, and defects from IT infrastructure platform qualification testing. Includes a statement on whether overall acceptance criteria from the Test Plan have been met.

Automatically maintained in SOLMAN, providing end-to-end traceability from requirements through test cases and execution. Used by Validation Lead during Work Package verification to confirm requirement coverage and approval completeness.

Defines user and regulatory requirements for a computerized system, managed in SOLMAN as a URS Document. Includes GxP ER/ES and audit trail requirements for regulatory systems. Lifecycle: Draft→Ready for Review→Ready for Approval→Approved.

Documentation of stakeholder needs and functional requirements for an Informatics solution, supporting both waterfall and agile development methodologies in line with CSV procedures.

A CSV framework template and project deliverable that defines the validation approach, scope, roles, and testing strategy for a computerized system implementation project. Jointly owned with PMM process owners.

A CSV artifact owned by the CSV Process Owner that documents the results of all validation activities and provides formal evidence that a computerized system meets its intended use and regulatory requirements.

Summarizes all validation activities and associated documentation. Includes high-level test results, deviations, outstanding defects, residual risks with mitigation recommendations, and a clear statement of system acceptability. May be titled Assurance Report or Release Summary.

SOLMAN Work Package grouping related deliverables and changes for a release. For GxP and ICFR relevant systems, Validation Lead verifies requirement coverage, approvals, traceability, and ASPIRE SolMan methodology adherence, then sets 'CSV review status' to 'Verified' before handover to Release.