FastVal Facilitates the Entire Validation Process
FastVal guides you through the entire validation process, allowing you to complete validation projects in 70% less time than using traditional validation methods; validation projects which took months can be completed within weeks using FastVal. FastVal:
FastVal is designed to incorporate all quality guidelines, including ICH and GAMP 4/GAMP 5, and to seamlessly integrate with your company's established SOPs and guidelines for computer validation. FastVal is completely compliant with 21 CFR 11. FastVal includes templates that can be used out of the box or customized to match your existing corporate templates.
Add Value to Everyone in the Validation Team
- System Owners use FastVal to produce validation documents quickly and accurately
- Validation Testing Professionals use FastVal to electronically execute test protocols
- Quality Assurance uses FastVal to track and resolve deviation investigations and reviews validation documentation
- Project Managers use FastVal project management tools to supervise the entire validation process and track project status in real time.
Automate Validation Document Generation
The FastVal automates the generation of validation documents. After creating a list of system Requirements, FastVal generates Specification documents and test protocols based on those requirements. FastVal can generate any validation document, including:
- Validation Master Plans and Validation Plans
- User Requirement Specifications
- Functional Requirement Specifications
- Design Specifications
- Installation/Operational/Performance Qualifications
- User Acceptance Testing
- Factory Acceptance Testing
- Site Acceptance Testing
- Software Acceptance Testing
- Test Plans
- Test Cases
- Risk Assessments
- Traceability Matrices
- Summary Reports
All documents can be created as PDFs or exported to MS Word.
Electronic Test Protocol Execution
FastVal allows users to execute all test protocols electronically. FastVal displays the procedure and expected results; testers record the actual results using text and screen shots. Instead of Testers keeping up with dozens of attached screen shots, FastVal automatically integrates this data into the final testing document. If deviations are identified, a Deviation report is automatically created. Quality Assurance has the ability to investigate, review and track deviations in real-time. All testing and document generation is compliant with 21 CFR 11.
Additional Information
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Validation Document Generator
