Computer System Validation
Demonstrating that regulated systems perform as intended through structured, traceable, and compliant validation.
Documented Confidence in System Fitness and Control
Computer System Validation establishes documented evidence that computerized systems used in regulated environments perform as intended and maintain control over data, records, and operational functions throughout their lifecycle.
Anthem helps organizations plan and execute validation activities that are risk-based, traceable, and aligned with intended use. We support validation strategy development, protocol authoring, test execution, evidence review, deviation handling, and deliverable completion so clients can move forward with documentation and execution that stand up to internal review, QA expectations, and regulatory scrutiny.
Validation Lifecycle Services
Our validation support covers the full set of activities required to build documented confidence in system performance, control, and fitness for intended use.
Validation Planning
We develop structured validation strategies for new and existing computerized systems so that the validation approach is aligned with system impact, intended use, and regulatory expectations.
- Validation Planning and Strategy
- System Risk Assessments
- Supplier Assessment Support
- Validation Summary Reports
Validation Documentation Development
We develop validation documentation packages that create clear alignment between requirements, design intent, and validation execution while supporting traceability, control, and inspection readiness.
- User Requirements Specifications
- Functional Specifications
- Configuration Specifications
- Design Specifications
- Risk Assessments
Protocol Development and Execution
We design and execute risk-based testing protocols to demonstrate that system functions operate as intended and that key controls perform reliably in the regulated environment.
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Configuration Verification
Traceability and Evidence Management
Validation is strengthened by clear traceability between requirements, test steps, results, deviations, and final conclusions. We support evidence organization in a way that improves transparency and inspection readiness.
- Requirements Traceability Matrix
- Evidence Referencing and Mapping
- Deviation and Defect Tracking
- Validation Closure Support
Core Deliverables That Support Validation Readiness
System Categories We Validate
Our validation experience spans a broad range of computerized systems used across business, laboratory, manufacturing, and infrastructure environments.
Enterprise Systems
- ERP Platforms
- Quality Management Systems
- Document Management Systems
- Learning Management Systems
Laboratory Systems
- LIMS
- Chromatography Data Systems
- Analytical Instrument Software
- Laboratory Data Management Tools
Manufacturing Systems
- SCADA and PLC-Based Systems
- Manufacturing Execution Systems
- Process Control Platforms
- Electronic Batch-Related Solutions
Infrastructure Systems
- Virtualized Environments
- Backup and Archive Systems
- Server and Supporting Infrastructure
- Critical Excel-Based Applications
Aligned with Recognized Compliance Expectations
Anthem delivers services with an approach shaped by established regulatory and industry standards, including 21 CFR Part 11, GAMP 5, ISPE guidance, and broader global expectations for computerized systems in regulated settings.
Validation that holds up under review, audits and inspections.
Connect with Anthem to support your system validation program with structure, traceability, and practical regulatory alignment.
Contact Us