In the demanding pharma and life sciences sectors, robust computer system validation is essential for compliance and efficiency. GoVal simplifies the validation lifecycle, empowering engineers, regulatory experts, and IT managers to maintain compliance, minimize manual tasks, and achieve seamless system integration.
[ GOVAL'S LIFECYCLE APPROACH ]
Streamlining Computer System Validation
GoVal guides you through a complete computer system validation journey, ensuring efficiency and compliance at every stage.
Effortless Project Initiation
Begin validation swiftly. Our user-friendly creation tools simplify project and system launches.
Proactive Risk Assessment
Proactively identify operational, and functional risks through intuitive GxP and initial risk assessments.
Strategic Validation Planning
Develop a customized validation plan and strategy based on your initial risk assessments.
Complete Requirements Capture
Capture essential business, regulatory, and operational needs for comprehensive system validation.
Detailed Functional Risk Analysis
Ensure complete risk coverage by utilizing FMEA or FRA modules to identify, analyze, and prioritize potential issues.
Regulatory Compliance
Streamlined compliance with 21 CFR Part 11 and Annex 11 was facilitated by our platform’s electronic signature, access, and audit trail capabilities.
Tailored Test Case Development
Create project-specific test cases, including Installation Qualification, Operational Qualification, and Performance Qualification.
Efficient Test Execution & Discrepancy
Accelerate testing with scripted execution, real-time evidence capture, and automated discrepancy resolution.
Reporting & Digital Approvals
Automate report generation and simplify document approvals with electronic signatures and reviews.
[ GOVAL VALIDATION WORKFLOW ]
How GoVal Enhances Validation Processes
1 Streamlined Project Initiation and Risk Assessment
- Create & Configure Projects: Easily set up projects and systems within GoVal.
- Comprehensive GxP Risk Assessment: Assess initial risks by evaluating multiple requirement categories—ensuring you cover regulatory, operational, and IT aspects.
- Real-Time Feedback: Immediate insights help shape a robust validation strategy.
2 Robust Validation Planning and Documentation
- Custom Validation Plans: Develop strategies that align with FDA 21 CFR Part 11, EMA EU Annex 11, and other key standards.
- Structured Requirement Capture: Record business, regulatory, and operational requirements in a unified interface for better traceability.
- Tailored Documentation: Generate sections like introductions, scopes, and validation strategies automatically using integrated AI tools.
3 Efficient Test Case Management
- Automated Test Case Drafting: Quickly generate IQ, OQ, and PQ test cases from your documented requirements.
- Scripted & Exploratory Testing: Execute both planned and ad-hoc tests, capturing actual results and evidence seamlessly.
- Discrepancy Handling: Create discrepancy forms on the fly, manage non-conformities, and ensure timely retesting.
4 Comprehensive Reporting and Digital Workflow
- Traceability & Audit-Ready Reports: For easy review, create dynamic, compliant matrices and validation summary reports.
- Digital Document Routing: Streamline document approvals with automated PDF routing, e-signatures, and audit-ready reviews.
- Centralized Data Repository: All validation data is stored in a secure, centralized database for easy access and future audits.
Ready to Transform Your Validation Process?
Experience the future of computer system validation with GoVal. Request a Demo today to see how our solution can streamline your validation lifecycle management, ensuring compliance, efficiency, and seamless integration across your organization.