Total Validation Process Control with FastVal

Rapid Process Validation

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 documents and create traceability matrices. FastVal generates traceability matrices, risk assessments, validation summary reports, and change control reports at the click of a button.

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.

Validation Document Generation

FastVal can generate any document required by your validation process. Using your existing templates FastVal can match content and formatting to quickly create documents that work seamlessly with your projects. Designed with accuracy and rapid deployment in mind FastVal automation tools allow users to cut down the times of their projects by 70% compared to traditional methods.

FastVal also automates the validation process in full compliance with 21 CFR 11. After the creation of a document users can apply a fully 21 CFR 11 compliant electronic signature to any document, preventing the document from being edited or updated. FastVal’s validation tools also include templates and creation wizards for many commonly used validation documents such as:

Comprehensive Automation of Validation Processes, Including:

• Validation Plans
• User Requirements Specifications, Functional Specifications and Design Specifications
• Requirements Traceability Matrix
• Test Protocols
• Summary Reports
• Deviation Summary Reports

Project Management

FastVal provides you with total control over your validation process. Quality managers can view the status of any project, any validation deliverable within a project, or any deviation associated with a validation project. FastVal allows you to focus your validation resources exactly where they need to be to complete your most critical projects and get the most out of your validation department.

• Project Tasks – FastVal tracks all tasks within a project. You can assign tasks to specific people or groups, and track project tasks by completion date or task priority. FastVal will send users alerts for overdue tasks, documents, or projects to assist in time and resource management.
• Document Status– FastVal lets you know the status of any document in real-time, including the specific sections that have outstanding questions or require additional information. FastVal facilitates collaboration between members of the project team and subject matter experts and ensures that the right people get the right information so documents can be completed, reviewed, and approved.
• Project Status– FastVal displays the entire status of a validation project at a glance, including requirements, specifications, test protocols, traceability, and testing deviations. FastVal can track multiple associated validation projects and place alerts in areas that require attention.
• Validation Metrics– FastVal lets you evaluate the performance of your validation project with a series of metrics designed to illustrate key performance indicators. FastVal tracks the time required to execute protocols, close deviations, or complete projects.

Validation Methodology

How can FastVal improve your team’s speed and productivity over traditional validation methods without sacrificing quality?

• Industry Proven Document Templates– Our validation professionals gather information about your system and its requirements. This information is entered into FastVal and it creates a template. This template forms the backbone of the validation document.
• Integrated Risk Assessment Our validation methodology reviews business functionality and system code. Based on these reviews, we focus validation resources appropriately so high risk portions of the program are exhaustively tested and lower risk portions of the program receive appropriate validation effort.
• Automatically-created Test Cases, Traceability Matrices, Deviation Summary Reports, Validation Summary Reports and more!– FastVal automatically creates documents and reports in 70% less time than traditional validation methods.
• Electronic Document Management FastVal provides us the technological tools to approve documents electronically. Project managers can check the status of documents. Signatories can apply an electronic signature when the document meets with their approval. Electronic document acceptance means no paper documents to walk around, no paper documents to lose, and knowing exactly who needs to approve the document.

FastVal facilitates the generation of validation documents creating documents and reports that take traditional methods hours or days to complete. We use the saved time to carefully test your system, focusing efforts on the highest risk sections of the program. We perform 100% dry-runs of testing protocols to identify and resolve deviations before formal testing begins. We understand that the fundamental goal of validation is to raise the value of your software.