For any types of Validation requirements

Govalidation is a web-based application that helps 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.

The system requires Zero paper usage and 100% electronic way of document generation.

paperless validation needs

Why we need to go for Paperless validation

  • Facilitates best practice system for method validation
  • Risk-based approach for each URS and helps to propose medication plan and test case to overcome the risk.
  • Eliminates 100% of paper-records with digital transformation.
  • Paperless test execution with integrated deviation management
  • Productivity improvement of up to 100%*
  • 21 CFR Part 11/EudraLex Annex 11 compliant
  • Manual errors will be avoided or minimised
  • 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.

Validation Strategy

  • Validation master plan
  • Design review
  • User Requirements specification, allows to categories and priorities the requirements.
  • Risk assessment management
  • Document review & approval
  • Paperless test execution with integrated deviation management
  • Validation summary report
  • Real time validation status & metrics
  • Traceability Matrix
  • Freeze validation, Change management and re-validation.
validation life cycle Workflow-based

paperless validation features

Features

  • Detailed Project setup as per the project requirement
  • Validation Project planner module
  • Risk assessment
  • Build custom templates using an existing word/excel document
  • Dynamic Form builder & Master control
  • Review and Approval process
  • Test case creation and Execution
  • Automatic traceability matrix
  • PDF Export with user-defined settings to generate validation documents
  • Custom alerts and email notification.
  • End-to-end audit trails in compliance with GAMP and CFR standards

Key Benefits

  • Quick Validation Project setup based on GAMP category.
  • Parallel execution of test scripts with screen recording features.
  • In-depth analysis of test case and their results can be shown.
  • Automated Workflow for each document with Electronic signature
  • In build Document management system to store the generated PDF documents.
  • System has interface to connect to external DMS like Sharepoint, FileNet.
  • Collobrate in real time with multiple users.
  • Easy to configure and use- Knowledge base.
  • Predefined templates and best practice followed across the industries
paperless validation key benefits


Want to see a live demo

If you would like to discuss how it can do transformation of your existing process, please contact us