GoVal was founded on the principle that validation should be efficient, compliant, and accessible. We recognized the challenges faced by life science companies relying on outdated, paper-based systems. With a team of validation and technology experts, we developed a robust digital platform to revolutionize the industry.
Simplify and streamline GxP compliance software processes for the life sciences industry through our validation automation platform and pharmaceutical validation software solutions, enabling our clients to achieve faster compliance and reduce manual effort.
Envision a future where Paperless Validation Solutions, Validation Lifecycle Management System (VLMS), and digital transformation validation are the standard across life sciences validation, driving innovation and ensuring the highest quality standards in life science product development.
Trusted by GxP-regulated organisations worldwide
GoVal's GAMP 5 Validation Software is built on industry best practices and ISPE guidelines. Our platform accelerates CSV projects by automating risk-based activities, ensuring compliance with Annex 11 and 21 CFR Part 11, and reducing manual effort by up to 60%.
We combine technical innovation with deep regulatory expertise to deliver a validation platform that life sciences teams trust.
Ensuring strict adherence to 21 CFR Part 11 and EU Annex 11 requirements while dramatically reducing compliance bottlenecks.
Continuously improving our platform and services to integrate the latest validation methodologies and technological advancements.
Maintaining complete transparency, robust data integrity, and unwavering trust in all our customer and regulatory interactions.
Prioritizing the exact needs, workflows, and operational success of our clients in the pharmaceutical and biotech sectors.
Focusing validation efforts on critical systems while intelligently reducing the documentation burden on low-risk components.
Leveraging machine learning to accelerate test protocol generation, streamline risk assessments, and enhance analytical insights.
GAMP 5 (Good Automated Manufacturing Practice) is ISPE's risk-based framework for computerized system validation (CSV). It emphasizes quality by design, categorizes software by risk level, and tailors validation effort to patient safety, product quality, and data integrity requirements.
Paperless validation uses digital tools to replace manual, paper-based processes. It automates document generation, electronic signatures, and audit trails, enabling audit-ready workflows while reducing errors and compliance risk in GxP environments.
GoVal enforces GxP compliance with validated electronic signatures, tamper-evident audit trails, role-based access controls, and automated risk-based CSV workflows that align with 21 CFR Part 11, Annex 11, and GAMP 5 requirements.
Risk-based validation focuses resources on high-impact systems and processes, reducing documentation burden while ensuring data integrity and compliance. It accelerates CSV by targeting critical areas, improving efficiency and audit readiness.
GoVal's Validation Lifecycle Management System (VLMS) makes implementing Computerized System Validation (CSV) seamless and compliant. Define user requirements and functional specifications within the platform, configure document templates to match your SOPs, and apply risk assessments in line with GAMP 5 and regulatory guidance.
Execute and manage test scripts digitally with real-time collaboration, and automatically capture system-generated audit trails for inspection readiness. GoVal's intuitive interface and AI-powered insights streamline every step — from planning to execution — reducing validation cycle time, improving data integrity, and ensuring teams stay audit-ready at all times.
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures. It requires controls for data integrity, system validation, audit trails, and user authentication in life sciences software systems.
Annex 11 is the EU's GMP guideline for computerized systems. It mandates validated software, data integrity controls, electronic signatures, change management, and audit trails to ensure regulatory compliance.
Paperless validation increases productivity, enhances data integrity, and improves audit readiness. Automated workflows minimize manual errors, accelerate compliance, and provide real-time visibility into validation activities.
A VLMS software centralizes requirements, test cases, and audit trails into one Digital Validation Platform, ensuring traceability and audit readiness across GxP processes.
A SaaS validation platform life sciences solution provides cloud-based GxP compliance automation tools, enabling organizations to implement risk-based validation approach methodologies without infrastructure overhead.
Join leading life science organizations who trust GoVal for their digital validation solutions. Let's get started!