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In the demanding life sciences landscape, robust computer system validation is the bedrock of 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 across all sectors.
While the principles of GxP remain constant, their application varies significantly across different domains. A truly effective validation platform must be flexible enough to address the unique challenges of each.
[ TAILORED VALIDATION FOR EVERY LIFE SCIENCE SECTOR ]
Adapting to Specialized Compliance Needs
GoVal provides a unified framework to manage validation for biotechnology, medical devices, and clinical trials, ensuring that specific regulatory demands are met with precision and efficiency.
Biotechnology Validation
Ensure the integrity of bioprocessing systems, from R&D labs to manufacturing. Manage validation for bioreactors, chromatography systems, and data analysis software with complete traceability.
Medical Device Validation
Meet the stringent requirements of FDA 21 CFR Part 820 and ISO 13485. GoVal streamlines validation for SaMD (Software as a Medical Device), manufacturing equipment, and QMS platforms.
Clinical Trial Validation
Guarantee the reliability of systems used in clinical research, including EDC, CTMS, and eTMF. Ensure data integrity and compliance with GCP standards from Phase I to submission.
[ GOVAL'S UNIFIED 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.
Ready to Unify Your Validation Process?
Experience the future of validation with GoVal. Request a Demo today to see how our single solution can streamline your lifecycle management across biotechnology, medical devices, and clinical trials, ensuring compliance and efficiency for your entire organization.