The FastVal Validation Document Generator creates, manages and executes validation documents. FastVal:

• Reduces time spent on validation projects by up to 70%
• Facilitates validation project management
• Produces any document your company requires for validation
• Provides requirement traceability throughout the validation process
• Automatically generates deviations if actual test results do not meet expected test results
  
• is 21 CFR 11 compliant, including electronic signatures and audit trails
• View a screen shot of the program document process

Project Management Tools

• Managers can view current status of all documents within a project, across all projects, or any section of any individual document
  
• FastVal facilitates collaboration by allowing reviewers to make public or private comments on any document and any line within a document
• View a screen shot of the document status summary screen and report

Validation Document Generation

The FastVal Document Generator generates any validation document, including:

• Validation Master Plans
• User Requirement Specifications
• Functional Requirement Specifications
• Design Specifications
• Test Protocols, including Installation, Operational and Performance Protocols
• Deviation Reports
• Summary Reports
• View a screen shot of the document management screen.

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