FastVal and Validation Methodology

How do FastVal and our validation methodology allow us to complete projects in 70% less time than 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 that traditional validation methods take hours or days to complete.
• Electronic Document Acceptance – FastVal provides us the technological tools to approve documents electronically. Project managers can check the status of validation 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.
• Electronic Protocol Execution – FastVal allows users to execute their testing protocols. Users can document their testing with screen shots and integrate the screen shots into the final testing documents.
• Straight Forward Validation Methodology – Our validation professionals are trained to focus right on the GxP portions of the program which require validation. Screens are tested for correct inputs, processing, outputs, and security requirements. Workflows are identified and tested to ensure they meet business requirements. Systems are tested to ensure compliance with 21 CFR 11.

Simply stated, FastVal facilitates the generation of validation documents creating documents and reports that take traditional validation methods hours or days to complete. We use the saved time to carefully test your system, focusing validation 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.

Our validation professionals are skilled in defining system requirements and testing those requirements appropriately and thoroughly without spending unnecessary time on inappropriate testing or unnecessary work. For example, one of our validation professionals:

• Validated a laboratory tracking database with 82 Screens with a total of 748 requirements, creating a Functional Requirements Specification, Design Specification, Installation/Operational Test Protocol (including 54 Test Cases and 1883 Test Steps), Traceability Matrix and Summary Report in eight weeks.
• Validated an equipment tracking database with 20 Screens with a total of 143 requirements, creating a Functional Requirements Specification, Design Specification, Installation/Operational Test Protocol (including 26 Test Cases and 475 Test Steps), Traceability Matrix and Summary Report in four weeks.
• Validated a relational database with 78 Screens with a total of 290 requirements, creating a Functional Requirements Specification, Design Specification, Installation/Operational Test Protocol (including 48 Test Cases and 1485 Test Steps), Traceability Matrix and Summary Report in five weeks.
• Validated a clinical trial database with 16 Screens with a total of 116 requirements, creating a Functional Requirements Specification, Design Specification, Installation/Operational Test Protocol (including 27 Test Cases and 715 Test Steps), Traceability Matrix and Summary Report in two weeks.

In each case, our validation efforts were reviewed by local Quality reviewers and approved as meeting or exceeding their standards.