New System or Major Implementation
Define the intended use, requirements, risk-based lifecycle and evidence package before regulated use.
GxP COMPUTERIZED SYSTEMS
Risk-Based Computerized Systems Validation Across the System Lifecycle
Labmerit supports risk-based validation of GxP-relevant computerized systems from intended use, requirements and supplier assessment through specification review, testing, traceability, reporting, periodic review and change assessment. We help regulated organizations build documented evidence that systems are fit for intended use and that critical functions, electronic records and data-integrity controls are appropriately verified and maintained.
Risk-based lifecycle validation
Intended-use and requirements focus
Traceable verification evidence
Data integrity and operational controls
From New Systems to Lifecycle Maintenance
Computerized Systems Validation support is needed when GxP systems are introduced, configured, integrated, migrated or upgraded - and when existing evidence, controls or lifecycle records must be reviewed, remediated or maintained.
Configuration, Integration or Data Migration
Verify configured functions, data flows, interfaces, migration controls and business-process requirements.
Upgrade, Release or Infrastructure Change
Assess impact and perform proportionate verification before approved release.
Legacy-System Remediation and Audit Readiness
Address gaps in requirements, supplier evidence, testing, traceability, data-integrity controls or lifecycle documentation.
Periodic Review and Validated-State Maintenance
Evaluate performance, incidents, changes, access, audit trails, backup, security and other relevant controls at defined intervals.
Systems Covered and CSV Scope
The exact scope is tailored to the intended use, GxP and data-integrity risk, system architecture, configuration, interfaces, supplier evidence, lifecycle stage, applicable requirements and the client quality system.
Systems Covered
- Environmental Monitoring Systems (EMS) for warehouses, cold rooms, production and laboratory areas
- Building Management Systems (BMS) for facility and cleanroom monitoring and control
- SCADA, Process Control Systems (PCS) and automation applications, including HVAC and cleanroom control and monitoring
- Enterprise Resource Planning (ERP), Warehouse Management Systems (WMS) and interfaces with 3PL or external systems
- Laboratory Management Systems and Laboratory Information Management Systems (LMS/LIMS)
- Quality Management Systems and electronic Quality Management Systems (QMS/eQMS)
- SaaS, cloud-based, on-premise and other GxP-relevant applications
Lifecycle Validation Activities
- Validation Plan and lifecycle validation strategy
- User Requirements Specification support, intended-use definition and GxP scope
- supplier and system assessment
- risk assessment and risk-based verification strategy
- review or development support for FS, FDS, SDS and HDS, as applicable
- Installation Qualification, Operational Qualification and Performance Qualification protocols and test execution, as agreed
Operational Controls and Lifecycle Support
- Requirements Traceability Matrix and Validation Report
- user-access, role and security verification
- audit trail, data integrity, electronic-record and electronic-signature controls, where applicable
- backup, restore, business-continuity and data-retention controls
- alarm, notification, interface, data-exchange and migration testing
- periodic review, change-impact assessment and proportionate revalidation
KEY VALIDATION AND DATA INTEGRITY ELEMENTS
Evidence That Connects Intended Use, Risk and Verification
A defensible CSV package connects intended use, approved requirements, system and supplier knowledge, risk controls, configuration, verification evidence, data integrity, operational procedures and lifecycle maintenance. Depending on the scope, key elements may include:
Intended-use principle. A vendor product is not ‘validated’ in the abstract. The regulated organization must demonstrate that the configured system, interfaces, procedures and controls are fit for their intended GxP use.
- defined GxP scope, intended use, business process and accountable Process Owner and System Owner
- approved, risk-based user requirements that remain traceable through the lifecycle
- documented supplier and system assessment, including responsibilities and reliance on supplier evidence
- controlled configuration and specifications, current system description, data flows, interfaces and relevant infrastructure
- risk assessment linking critical functions, records and controls to proportionate verification
- a Requirements Traceability Matrix connecting requirements, risks, specifications and test evidence
- controlled test environments, methods, scenarios, expected results, objective evidence, deviations and acceptance decisions
- verified access, audit trail, data integrity, backup and restore, interfaces, alarms and other applicable operational controls
- approved procedures, trained users, incident and change management, periodic review, business continuity, archiving and retirement controls
A Risk-Based Computerized Systems Validation Lifecycle
Define
Confirm the intended use, GxP scope, business process, system boundaries, applicable requirements, lifecycle stage and responsibilities.
Assess
Evaluate the supplier, system, architecture, data and process risks and define the proportionate validation strategy.
Specify
Establish or review requirements, configuration and functional or design specifications and maintain traceability to critical risks.
Verify
Prepare and execute risk-based IQ, OQ, PQ or other agreed tests; capture objective evidence and manage deviations under control.
Evaluate and Report
Assess requirements coverage, residual risks, deviations, procedures and readiness and document the validation conclusion.
Maintain
Apply controlled operation, incident and change management, periodic review, impact assessment, proportionate revalidation and retirement planning.
Typical CSV Deliverables
Final deliverables, lifecycle documents, test execution, data sources, authorship and approval workflows are agreed for each assignment and aligned with the client quality system.
CLIENT, LABMERIT AND SUPPLIER RESPONSIBILITIES.
Labmerit may prepare validation documentation, coordinate or execute agreed tests, assess deviations and compile traceability and reporting. The client remains responsible for intended use, business-process and system ownership, approval of requirements and risk decisions, data governance, procedures, release for use and final approval. The supplier remains responsible for its product, design and configuration documentation, releases, defects and contracted support. A responsibility matrix is agreed for every assignment.
- Validation Plan or lifecycle validation strategy
- GxP impact assessment, system inventory entry or classification record
- User Requirements Specification
- supplier and system assessment
- computerized-system risk assessment
- review or development support for FS, FDS, SDS and HDS, as applicable
- IQ, OQ and PQ protocols and executed test records
- deviation records, assessments and resolution evidence
- Requirements Traceability Matrix and Validation Report
- periodic-review, change-impact or revalidation assessment
Connected Services - Clear Responsibilities
Commissioning and Qualification
Confirms that facilities, utilities, equipment and relevant infrastructure are designed, installed, operated and performing as intended.
Computerized Systems Validation
Demonstrates that the configured GxP application, functions, electronic records, interfaces and controls are fit for their defined intended use.
Process and Cleaning Validation
Build process-specific evidence for consistent manufacturing performance or reproducible cleaning effectiveness; they do not replace validation of the supporting computerized system.
Testing and Calibration
Provide specific technical or measurement results with their own scope, method, responsibility and accreditation status.
Integrated-system rule. Shared boundaries, interfaces and evidence must remain traceable. Qualification or calibration does not replace CSV, and CSV does not replace qualification, process validation, cleaning validation, testing or calibration.
Technical Evidence with a Clearly Defined Status
CSV may depend on configuration records, technical tests, environmental or measurement evidence and calibrated instruments. The source, responsibility, method and status of each supporting result must remain clear.
Computerized Systems Validation is a professional GxP service outside Labmerit accredited scopes.
Software-validation and data-integrity verification must not be presented as accredited ISO/IEC 17025 testing merely because they form part of a regulated project.
Specific technical testing is identified as accredited only when the exact activity is included in the valid Testing Laboratory Scope 01-303.
Calibration is identified as accredited only when the exact activity is included in the valid Calibration Laboratory Scope 02-071.
Every proposal and report must identify the status of each specific activity; accreditation is never inferred from proximity to CSV.
Computerized Systems Validation is provided as a professional GxP service outside Labmerit accredited scopes. If a project includes specific technical testing within Scope 01-303 or calibration within Scope 02-071, only those identified activities and results are presented as accredited.
Aligned with Applicable GxP and Risk-Based Principles
Our approach is tailored to the intended use, GxP and data-integrity risk, system lifecycle, target market and client quality system and may consider, as relevant:
- EU GMP Annex 11 - Computerised Systems
- EU GMP Annex 15 - Qualification and Validation
- 21 CFR Part 11 - Electronic Records; Electronic Signatures, where applicable
- FDA Computer Software Assurance principles for production and quality management system software, where applicable
- ICH Q9(R1) Quality Risk Management
- GAMP 5 (Second Edition) principles
- applicable GDP, client and target-market requirements
Only frameworks relevant to the specific project are applied. References reflect the currently applicable versions and do not represent a claim of certification, accreditation or regulatory approval.
Why Clients Choose Labmerit
Multidisciplinary delivery. CSV, QA, IT, automation, engineering, qualification, measurement and validation expertise can be coordinated within one project structure.
Lifecycle continuity. Support can extend from intended use, requirements and supplier assessment to testing, reporting, periodic review and change assessment.
Broad system coverage. Experience spans monitoring, building and process control, enterprise, warehouse, laboratory, quality and cloud-based GxP systems.
Risk-based focus. Validation effort is directed toward critical functions, records, interfaces and controls that matter to product quality, patient safety and data integrity.
Traceable documentation. Requirements, risks, specifications, tests, deviations, controls, reports and approvals are structured for lifecycle review and audit readiness.
International experience. Project experience across Europe and the Kingdom of Saudi Arabia (KSA).
Planning a New GxP System, Upgrade or Remediation?
Tell us about the system, intended use, business process, lifecycle stage and validation challenge. Our team will help define an appropriate scope, responsibility model, documentation set, risk-based test strategy and lifecycle plan.
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