FastVal and Validation Methodology

How do FastVal and our validation methodology allow us to complete projects in 70% of the time as more 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 Traceability Matrices, Summaries of test cases, Deviations and Test Results – FastVal automatically creates documents and reports automatically, which traditional validation methods take hours or days to complete.


• Automatic Generation of Common Test Steps – FastVal automatically inserts common test steps, such as screen navigation, entering data into fields, printing, etc. These micro test cases are combined to form the backbone of test cases.


• Tracing Requirements to Individual Test Steps – FastVal links requirements outlined in the Functional requirements to specific Design requirements. These requirements are then automatically linked to the appropriate steps in the test cases. The Traceability Matrix can be viewed in real-time to know the status of the project and Quality can navigate to the specific test steps to review that system functionality was appropriately tested.


• Electronic Document Acceptance – FastVal provides us the technological tools to approved 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 loose 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. Work-flows 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.