TRAIN TRACK® Version 9 has been fully validated according to industry standards. Validation is a formalized, documented process for testing computer systems and controlled processes. The FDA and other regulatory bodies require validation of computer systems to ensure that these systems are in compliance with all applicable regulations.

• Validation was conducted by Quality and Compliance experts with extensive experience working with the FDA and other regulatory agencies.
• Version 9 was validated prior to release, and an additional validation of the final installed version was conducted on-site at a pharmaceutical manufacturing facility.
• The review team verified that TRAIN TRACK® meets all specified requirements.
• The complete validation and design package, including all documentation, can be purchased separately.

The Design Documents provide detailed information about the program architecture and logic. Our Validation Package includes complete documentation in both .pdf and open document formats. You may use the editable versions of the documents to conduct additional validation activities, and incorporate them into your own document control and quality assurance systems.

Validation Package Contents:

• Software Requirements Specification (SRS): Describes in detail all of the required features of the software.
• Software Design Specification (SDS): Describes how the program carries out the required functions, and explains the architecture and logic.
• Functional Test Specification (FTS): Detailed installation qualification and test protocol with step-by-step testing instructions and test criteria to ensure that all requirements are met.
• Functional Test Specification (FTS) Sample Execution: Documentation of the execution of the test specification and actual test results.
• Requirements Traceability Matrix (RTM): A matrix tracing each requirement from the SRS to the SDS and FTS to ensure that all requirements are documented and tested.
• Validation Summary Report (VSR): Description of the validation process and conclusion.

Digital Validation Package: $999*

• Digital copy of each document in an editable format.
• Digital copy of each document in a locked format.
• A printed copy (including shipping to US zip codes) may be purchased for an additional $79.99*.

*Prices are US Dollars and subject to change without notice.

Background Information

Here are some links to more information about validation and 21 CFR Part 11:

General Principles of Software Validation (FDA Web site)

Wikipedia entry for Software Verification and Validation

Software Validation in Accredited Laboratories: A Practical Guide

IT SOFTWARE VALIDATION