FastVal – System Details

Manage and Automate Your Validation Process

FastVal was created by experts in 21 CFR 11 who needed tools to improve, automate, and manage their validation projects. Their goals were to spend less time creating validation documents and more time testing and to improve management of their validation staff.

FastVal automates the validation process in full compliance with 21 CFR 11, including audit trails and electronic signatures. FastVal guides validation professionals through the process of gathering system requirements. System requirements are used to create validation documents and create traceability matrices. FastVal generates traceability matrices, risk assessments, validation summary reports, and change control reports at the click of a button.

Managers can view the status of any document in real-time and provide public or private comments throughout. Managers can track and analyze data generated during validation in real-time, including document due dates, time to execute protocol steps, and deviations generated during protocol execution. Managers have access to an extensive array of Project Management and Metric Reports.

Project Management Tools and Validation Metrics

• Comprehensive – Track the status of each requirement and each document.
• Complete – Reports track all documents and statuses.
• Metrics – Calculate time until protocol execution is complete and average number of test case steps executed per hour.
• Change Control – Track re-validations and program revisions. Retest only requirements which have been changed.

Automate Your Validation Process

FastVal creates any document your process requires, including:

• Requirements and Protocols
  • User, Functional, and Design specifications
  • Installation, Operational, and Performance Qualifications
  • User, Factory, and Software Acceptance Tests
  • FastVal automates the creation of any validation document.
• Traceability Matrices – Requirement tracking is built into FastVal and can be customized to meet unique requirements.
• Risk Assessment – Evaluate the risk of each system requirement and generate risk reports.
• Validation Summary Reports – Automatically create a reports that include executed Test Cases, Deviations, and Resolutions.
• Data Migration – FastVal generates documentation for data migration protocols.
• Change Control – Automatically track all changes made to all of your validation documents and create a Change Control Report listing all changes.

All documents can be created as MS Word documents or PDF reports. Once created, the documents are standard Word or PDF documents and are maintained using your own document management processes.

Electronic Protocol Execution

• Validation testing can be executed and reviewed 100% electronically, or documents can be exported to support paper execution.
• Validation testing is documented with text and screen capture.
• Any deviations will automatically generate a Deviation Event Report to allow defect investigation and tracking through resolution.
• View a screen shot of the test case electronic execution screen.

Additional Compliance and Productivity Features

• FastVal produces a requirement list, providing traceability for requirements throughout the project.
• Built-in risk assessment capability
• Multi-user signature page for electronic signatures
• LDAP/Active Security interface for user authentication
• Documents can be printed in Word or PDF formats.