GoVal

GoVal is a paperless validation software solution developed by AdventSys, designed for Life Sciences and pharmaceutical organizations that need to achieve GxP compliance. It replaces paper-based validation processes with automated, electronic workflows, supporting document storage and retrieval in a controlled and secured environment. GoVal addresses FDA and EMA regulatory requirements, including 21 CFR Part 11 compliance, by enabling Computer System Validation (CSV) across GxP computerized systems.

Computer System Validation is a regulatory requirement for Life Sciences companies operating under GxP guidelines. A structured CSV program covers validation planning, testing, and documentation, helping organizations reduce non-compliance risk, identify issues early in development, and avoid costly delays or product recalls. GoVal is built to support this process end-to-end in a paperless format.

Validation Planning and Requirements Management

• Supports creation of a Master Validation Plan to identify validation strategies, testing requirements, and GxP systems to be validated.
• Allows definition of User Requirements Specifications (URS) and Functional Specifications (FS) using mapping and customization features.
• Includes a GxP assessment tool that determines the GAMP category of a system and suggests the required processes and documents for validation.

Risk-Based Validation and Testing

• Supports risk-based validation approaches for GxP computerized systems, with testing strategies based on the severity and probability of occurrence of functional requirements and processes.
• Provides GxP test protocol implementation using risk-based methodologies to guide testing of computerized systems.
• Auto-generates a Requirement Traceability Matrix (RTM) that links test cases, risks, requirements, and discrepancy details for failed tests back to URS entries.

Workflow Automation and Document Management

• Automates the validation workflow, including document review and approval processes.
• Supports electronic approval signatures for document sign-off, replacing manual paper-based approvals.
• Provides configurable approval workflows to match organizational processes.
• Allows definition of predefined document templates to standardize validation documentation.

Vendor Assessment

• Automates vendor assessment by sending electronic questionnaires to prospective vendors and collecting their responses within the platform.

Compliance Reporting

• Generates compliance reports from project data with a single action, including the Validation Summary Report, System Release Certificate, and Part 11 Compliance Certificate.
• Supports custom report generation to meet specific organizational or regulatory reporting needs.

Key Platform Features

• Configurable approval workflows
• Predefined and customizable document templates
• Custom report generation
• Electronic approval signatures
• Web-based application accessible via browser

GoVal is delivered as a web-based application, making it accessible without local installation. It is intended to support data integrity, consistency, control, and transparency across Life Sciences and pharmaceutical organizations. AdventSys, headquartered in Bangalore, India, provides the platform as part of its broader enterprise IT solutions portfolio.