Document Generation

FastVal can generate any document required by your validation process. Validation document content and formatting can be configured to match your existing templates. Documents can include pictures, tables, or embedded PDF content. Documents can also include comments to facilitate the review process.

Many validation documents, including requirements, specification, test protocols, and summary reports have wizards that guide validation document generation and content. These wizards guide users through the process of creating validation deliverables and ensure that all validation documents have the required sections and content.

Once the document review has been completed, users can apply a fully 21 CFR 11 compliant electronic signature to any document which will prevent the document from being edited. Validation documents can be stored within FastVal or exported to your existing document control system.

How FastVal Document Generation Process Benefits Your Validation Group

FastVal allows your validation group to focus on the content of the validation deliverables and not spend endless hours word-smithing or tweaking formatting. Using FastVal prevents standard copy and paste errors caused by reusing older validation projects, cutting down on needless errors and document review cycles. FastVal automatically generates more project specific content than using standard MS Word templates, allowing your validation group to focus on documenting specifications and writing testing that adds value to your organization. Customary document content, such as business requirements for every system or techniques for address specific FDA regulations can be standardized to ensure document uniformity.

Having a standardized approach to creating validation documents demonstrates control over your validation process. It ensures that all of your validation deliverables will have a uniform text and formatting, regardless of author. This uniform approach to validation documentation provides your Quality department with a high degree of assurance that you have total control over your validation process and can reduce overall time to review and approve validation deliverables.

FastVal Validation Document Generation

FastVal includes templates for all validation documents, including traceability matrices. Validation document content can be configured to your organization’s specific needs and exported to any MS Word document. FastVal can create any validation document your process requires, including:

• Validation Plans
• User Requirements
• Functional Requirements
• Design Specifications
• Installation Qualifications
• Operational Qualifications
• Performance Qualifications
• Deviation Reports
• Traceability Matrices
• Summary Reports

FastVal Key Features

• Project Management
• Validation Project Metrics
• Electronic Protocol Execution
• Automated Traceability Matrix Creation
• Automated Summary Report Creation