Computer System Validation
Software Validation Form
Document systematic software validation through risk assessment, testing, and compliance verification processes.
Summary
Software Validation Form provides structured documentation for validating computer systems and software applications used in quality management processes or production/service provision activities that impact medical device safety and quality. This essential Quality Management System (QMS) record ensures systematic evaluation of software reliability, performance, and compliance with regulatory requirements through risk-based validation approaches.Why is Software Validation Form important?
Computer system validation represents a regulatory requirement that ensures software systems perform consistently and reliably in ways that affect product quality or regulatory compliance. Without proper software validation, organizations risk using unverified systems that could introduce errors, data integrity issues, or compliance failures affecting medical device safety and effectiveness. ISO 13485:2016 mandates validation of processes where output cannot be verified through subsequent monitoring or measurement (Section 7.5.6). Software validation demonstrates that applications perform their intended functions accurately and maintain data integrity throughout their operational lifecycle. This protects against systematic errors that could affect multiple devices or compromise quality management system effectiveness. The structured validation approach transforms software evaluation from informal testing into systematic verification that supports regulatory compliance, audit readiness, and operational confidence. Well-executed software validation provides objective evidence that computer systems support rather than compromise quality objectives and regulatory requirements.Regulatory Context
Under 21 CFR Part 820 (Quality System Regulation) and 21 CFR Part 11 (Electronic Records):
- Process validation required for processes where output cannot be verified by subsequent inspection/test (21 CFR 820.75)
- Computer system validation must ensure software performs intended functions accurately and reliably
- Electronic signature systems must be validated per 21 CFR Part 11 requirements
- Data integrity requirements mandate validated systems for electronic records affecting device quality
Special attention required for:
- GAMP 5 guidelines for computer system validation approaches
- 21 CFR Part 11 compliance for systems managing electronic records/signatures
- Software as Medical Device (SaMD) development tool validation
- Quality system software supporting design controls, CAPA, and document management
Guide
Software Qualification and Risk Assessment
Determine validation requirements using qualification criteria that assess software impact on quality management systems and medical device safety. Evaluate three key questions: Does software failure affect device safety or quality? Does software automate regulatory-required activities? Could software output reach released products without verification? Conduct systematic risk assessment considering software impact on quality management systems, potential failure consequences, regulatory compliance requirements, and user impact scenarios. Categorize software risk levels as low, medium, or high based on assessment results to determine appropriate validation rigor and documentation requirements. Apply GAMP 5 categorization when appropriate, classifying software as infrastructure (Category 1), non-configurable commercial off-the-shelf (Category 3), configurable COTS (Category 4), or bespoke custom software (Category 5). Match validation approach to software category and risk level for efficient resource allocation.Software Requirements and Intended Use Definition
Document software intended use clearly, specifying exactly how your organization will utilize the software and which processes it will replace or support. Identify specific features your organization will use rather than cataloging all available software capabilities. Establish software requirements that define what the software must accomplish to meet your intended use. Structure requirements systematically using unique identifiers and clear, testable statements. Link requirements to risk controls and validation testing to ensure comprehensive coverage. Define software replacement scope by documenting existing processes the software will automate or replace. This establishes validation boundaries and helps determine which software functions require validation versus those outside your scope of use.Risk Management and Control Implementation
Identify software-related hazards that could lead to harm including device quality impacts, manufacturing process disruptions, regulatory compliance failures, or personnel/environmental safety concerns. Assess likelihood and severity of identified risks using structured risk acceptability matrices. Implement risk controls for unacceptable risks through software design modifications, process controls, user training, or downstream verification activities. Document risk control effectiveness and reassess residual risks after control implementation. Establish risk acceptability criteria based on software impact potential and your organization’s risk tolerance. Use structured matrices that consider harm severity (low, moderate, high) and occurrence likelihood (infrequent, occasional, regular) to guide risk management decisions.Validation Testing and Documentation
Develop comprehensive test plans that verify software requirements fulfillment and risk control effectiveness. Design test cases with clear objectives, detailed test steps, and specific acceptance criteria linked to software requirements. Establish appropriate test environments that represent actual software deployment conditions including hardware, operating systems, network configurations, and user access controls. Document test environment specifications to ensure validation relevance and reproducibility. Execute validation testing systematically with qualified personnel documenting test results, pass/fail determinations, and any deviations from expected performance. Include both positive and negative testing to verify software handles normal operations and error conditions appropriately. Document validation conclusions that summarize testing results, assess software suitability for intended use, and identify any limitations or restrictions for deployment. Address failed tests through software modifications, risk control adjustments, or use restriction implementation.Deployment and Ongoing Management
Plan software deployment considering integration with existing systems, user training requirements, transition timelines, and rollback procedures if issues arise. Document deployment processes to ensure consistent implementation and change control. Establish ongoing monitoring and review procedures proportionate to software risk and criticality. Define monitoring activities including periodic performance reviews, error log analysis, user feedback collection, and compliance verification. Maintain validation documentation throughout software lifecycle including version updates, configuration changes, and periodic revalidation activities. Update List of Validated Software to reflect current validation status and deployment information.Software Updates and Change Control
Evaluate software updates for impact on validated functions and previously identified risks. Determine revalidation requirements based on change scope, risk implications, and intended use modifications. Document change evaluation in validation records including assessment rationale, revalidation decisions, and any additional risk controls implemented. Maintain validation history showing software evolution and validation activities over time. Coordinate software validation with broader change management processes to ensure systematic evaluation and approval of software modifications affecting quality or compliance.Example
Scenario: Your organization implements a new electronic Quality Management System (eQMS) platform to replace paper-based document control and electronic signature processes. The eQMS will manage SOPs, training records, CAPA documentation, and audit reports for your Class IIa medical device.Software Qualification
You complete qualification criteria assessment determining the eQMS requires validation because it automates regulatory-required activities (document control, electronic signatures) and could impact device quality if it fails. Risk assessment identifies medium-to-high risk due to quality management system criticality and regulatory compliance requirements.Requirements Definition
Your software requirements specify document version control capabilities, electronic signature compliance, user access controls, audit trail functionality, and backup/recovery procedures. Intended use focuses on replacing paper-based QMS processes while maintaining regulatory traceability and compliance.Risk Assessment and Controls
You identify risks including data loss, unauthorized access, system downtime, and electronic signature non-compliance. Risk controls include automated backup systems, user authentication protocols, system redundancy, and 21 CFR Part 11 compliance features. Residual risks are assessed as acceptable after control implementation.Validation Testing
Your test plan includes document upload/download testing, electronic signature verification, user access control validation, audit trail functionality testing, and backup/recovery procedures verification. Testing occurs in production-equivalent environment with actual users performing typical QMS activities.Deployment and Monitoring
Following successful validation, you deploy the eQMS with phased user training and parallel operations during transition. Ongoing monitoring includes monthly system performance reviews, quarterly compliance audits, and annual validation effectiveness assessments. The validated eQMS is added to your List of Validated Software.Q&A
Which software applications require validation using this form?
Which software applications require validation using this form?
Validate software that automates regulatory-required activities, could affect device quality if it fails, or produces output that reaches released products without verification. Common examples include electronic QMS platforms, manufacturing control systems, laboratory data management systems, and design control software.
How do I determine the appropriate level of validation rigor?
How do I determine the appropriate level of validation rigor?
Base validation rigor on software risk assessment results and GAMP 5 categorization. High-risk or custom software requires comprehensive validation including detailed testing and documentation. Low-risk commercial software may require basic functional testing and configuration verification. Match validation effort to risk and complexity.
What constitutes adequate validation testing for software?
What constitutes adequate validation testing for software?
Validation testing must verify all software requirements are met and risk controls are effective. Include installation qualification, operational qualification, and performance qualification testing as appropriate. Test both normal operations and error conditions. Document test procedures, results, and acceptance criteria clearly.
How often should validated software be reviewed or revalidated?
How often should validated software be reviewed or revalidated?
Review validated software based on risk level and change frequency. High-risk systems may require annual reviews while low-risk systems might need review every 2-3 years. Revalidate when software versions change significantly, intended use expands, or new risks are identified. Document all review activities.
What should I do if validation testing reveals software deficiencies?
What should I do if validation testing reveals software deficiencies?
Address software deficiencies through software modifications, additional risk controls, use restrictions, or deployment delays. Document all issues and resolution approaches. Repeat testing after implementing corrective actions. Only deploy software after successful validation completion or with documented risk acceptance.
How do I handle validation for software-as-a-service (SaaS) applications?
How do I handle validation for software-as-a-service (SaaS) applications?
SaaS validation focuses on configuration verification, interface testing, and supplier assessment rather than underlying software development. Validate your specific configuration and integration while relying on supplier validation documentation for core functionality. Include supplier audits and service level agreements in validation approach.
What documentation should be maintained for validated software?
What documentation should be maintained for validated software?
Maintain completed Software Validation Forms, test protocols and results, risk assessments, software requirements specifications, and ongoing monitoring records. Include supplier documentation, configuration records, and validation history. Ensure documentation supports audit requirements and demonstrates ongoing compliance.
How does software validation relate to 21 CFR Part 11 compliance?
How does software validation relate to 21 CFR Part 11 compliance?
Software supporting electronic records or signatures must comply with 21 CFR Part 11 requirements including user authentication, audit trails, electronic signature controls, and data integrity protections. Include Part 11 compliance verification in validation testing and document compliance features and controls in validation records.