For any types of Validation requirements

 

GoVal helps the organization to perform the Validation life cycle in a digital way. A configurable workflow that helps to review & approve cycle automated way. The system is designed in compliance with 21 CFR part 11 and regulatory requirements, taking inputs from industry experts and followed the best standards

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Supports Both V Model and Agile Model

System helps to create Validation master plan, GxP impact assessment

Define User Requirements specification and prioritization, enable risk-based approach. Automated workflow, review & approval process. Supports both parallel and sequential workflow

Paperless execution of test scripts with integrated deviation management. Provides automated Traceability Matrix, Validation summary report and inventory report

Real time validation status & metrics. Helps to maintain and execute periodic review of all validated systems

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Zero paper usage and 100% electronic way

Ease to use and maintain. Eliminates 100% of paper-records with digital transformation. Facilitates best practice system in validation

Risk-based approach for requirements helps to propose mitigation plan and test case to overcome the risk. Paperless test execution with integrated deviation management

21 CFR Part 11/EudraLex Annex 11 compliant. Manual errors will be avoided or minimized. Clarity in execution of validation project with in-depth view of project status as on date. Audit ready system with real time data for review.

Overall Productivity improvement of up to 40%*

Client Stories

Key Features

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Projects

Create project plans for various types of validations such as Computer System Validation (CSV). Cleanroom Validation and Process Validation. Do GxP Assessments and identify GAMP category and process artifacts required for the validation project.

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Electronic Records

Create or upload requirement and project specification documents for the validation projects. Maintain 100% electronic records in the inbuilt Document Management System (DMS).

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Risk Assessment

Do Risk Assessment of project requirements and identify mitigation plans, assign required test plans for the mitigations. Handle residual risks.

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Test Management

Create test plans, test scripts for the validation project requirements. Capture the test execution results. Handle test outcome discrepancies.

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Workflow Automation

Validation Project artefacts goes through review and approval through workflow automation. The artefacts are approved with electronic signatures.

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Audit Trail

Capture the audit trail information of validation projects at different levels. View audit trail details through a comprehensive reporting interface.

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Reporting

View Validation Summary Report(VSR), get information on software / hardware inventory, generate Requirement Traceability Matrix (RTM), Test Execution Results

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Integration

Integrate third party applications such as external DMSs like SharePoint and service APIs with GoVal with ease.

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User Access Management

Comprehensive user access management console, Single Sign On (SSO) through LDAP Active directory integration, Notifications and alerts for the end users