Ofni Systems, a leader in providing regulatory compliance solutions for pharmaceutical, biotech and medical device companies announces the release of FastVal Validation Document Generator v3.0. FastVal allows users to complete validation projects in 70% less time than using traditional validation methods. FastVal is compliant with all FDA/EU rules for electronic records and signatures, including 21 CFR 11 and Annex 11 and implements industry recognized best practices for validation, including GAMP 5. This release enhances FastVal’s ability to help enable organizations execute all aspects of their validation projects with shorter timelines and increased quality.
- Creates All Required Validation Documentation – FastVal can generate any document your validation process requires. Many validation deliverables, included Requirement Traceability Matrices, Deviation Reports, Summary Reports and Change Control Reports can be created automatically through internal wizards. FastVal includes templates provided by Ofni Systems, or can be modified to use your organizations existing templates. All documents can be generated as Microsoft Word or PDF files.Key Features of the FastVal Document Generator include:
- Electronic Protocol Execution – FastVal allows users to execute test protocols electronically. Evidence of protocol execution is supported through text and screen capture. Electronic protocol execution uses electronic signatures to verify the identity of testers. Complete 21 CFR 11 audit trails document the protocol execution.
- Automatic Deviation Tracking – Deviations are created automatically when actual testing results do no match expected results. Deviations and be resolved internally within FastVal, or exported to your deviation tracking tool for resolution.
- Validation Project Management Tools – PStakeholders can see document and protocol status, follow deviations to resolution, and calculate validation metrics (including tracking requirement completion).
- Updated Test Protocol Creation Tools – The Microtest Writer provides templates for commonly used functionality. This allows for quick creation of test cases by providing an interface to replace specific variables which are then automatically integrated and used to populate the test scripts. Highlights of this release include:
- Updated Risk Assessment Tools – Responding to increased regulatory requirements in Annex 11 and FDA best practices, FastVal has an upgraded interface for documenting risk associated with validateable objects. Users document the risk associated with requirements and export the risk to either a Risk Assessment document or report.
- Requirements Burn-Down List – InteIntegrates the test writing function with the functional requirements and the Traceability Matrix providing visibility into which requirements have not been covered by corresponding test cases. Automatically links test cases to the functional requirements and system design specification to automatically create the customized trace matrix.
- Updated Metrics Reporting – The system provides complete transparency into the status of your project. The review status of all documentation can be viewed including the status of test case execution. The system contains integrated deviation reports and provides estimates of expected test execution completion based on current progress.
- Enhanced User Interface – The FastVal user interface has been harmonized and improved to facilitate new user training and program ease of use.
These enhancements increase FastVal’s ease of use and allow users to shorten the validation cycle while increasing the quality of the finished validation project. Managers have greater visibility into the status of validation projects and can have confidence that their validated system will withstand regulatory scrutiny. “Validation should add value to a computer system,” said Ofni Systems Validation Manager Ofni Systems. “FastVal produces higher quality documentation, in far less time, which in turn allows us to spend our time testing software, rather than generating documentation. FastVal can be customized to any customer validation requirements, which allows us to meet and exceed all of our customer’s standards.”
Ofni Systems, Inc.
Phone: (919) 844 – 2494
About Ofni Systems
Ofni Systems is an industry leader for 21 CFR Part 11/Annex 11 compliance and automating the validation process. Started in 1999, their products for compliant databases and spreadsheets are used by the FDA, pharmaceutical, biotech and medical device companies across the globe. They are the creators of ExcelSafe for Excel spreadsheet security and the Part 11 Toolkit for compliant databases. They also are the creators of the FastVal validation software for generating and executing validation documents, and have been providing professional validation services using FastVal since 2006. The company’s products for computer validation, auditing and FDA submissions ensure that their clients meet all requirements for electronic records and electronic signatures. Ofni Systems provides live desktop support for superior customer support and training. For more information, call (919) 844-2494 or visit www.OfniSystems.com.