Manage and Maximize Your Validation Process

Validation managers are expected to perform more validations while meeting higher regulatory expectations with fewer resources. FastVal is the tool that validation experts use to meet and exceed these expectations for validation projects for more than five years.

Ofni Systems is pleased to announce the release of FastVal 2.0. FastVal:

• Allows 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
• Integrates into your existing quality systems and validation process
• Facilitates the process of gathering system requirements
• Automates validation document generation
• Creates documents as MS Word documents or PDF Reports
• Creates Requirement Traceability Matrix automatically
• Allows electronic execution of test protocols with integrated screen shots
• Produces Deviation Reports automatically when test steps do not perform as expected
• Exports deviation reports to your existing CAPA system, or track and resolve deviations in FastVal.
• Track and report on project status with extensive Project Management tools
• Generates the Validation Summary Report, including test cases and deviations.
• Tracks changes to validation documents, including automatically producing Change Control reports

FastVal is designed to incorporate all quality guidelines, including ICH and 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 can be customized to match your existing corporate validation templates and verbiage; you can also use text and templates included in FastVal.

The Entire Validation Team Benefits from FastVal

• System Owners and Document Authors use FastVal to produce validation documents quickly and accurately. Reviewers can add public or private comments on any document and any line within a document
• Validation Professionals use FastVal to automate document creation and electronically execute test protocols
• Quality Assurance uses FastVal to track and resolve deviation investigations and reviews validation documentation
• Validation Project Managers use FastVal project management tools to supervise the entire validation process. Managers track project status in real time, receive updating estimates for project completion and generate validation metrics, including time to execute test case steps.

Execute Protocols Electronically or on Paper

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

• More Information about FastVal
• Reduce the time spent on validation projects by 70%
• Read the FastVal Frequently Asked Questions
• Request a demonstration of FastVal
• Ofni Systems Validation Services