Software Validation Form

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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.

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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.

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Regulatory Context

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Guide

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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Q&A