VALIDATION AND REGULATORY COMPLIANCE

VALIDATION

A Validation Package is now available for TRAIN TRACK™.

Validation is a formalized, documented process for testing computer systems and controlled processes. The FDA and other regulatory bodies require validation of computer systems, equipment, GxP processes and cleaning to ensure that these systems and processes are in compliance with all applicable regulations.

Validation is conducted by experts from an outside company with extensive experience working with the FDA and other regulatory agencies. Our Validation Package includes complete documentation:

Validation Package Contents:

• Functional Requirements Specification.
• Software Design Specification.
• Installation/Operational Qualification Protocol.
• Installation/Operational Qualification Sample Execution.
• Custom Requirements Traceability Matrix.
• Validation Summary Report.

The validation package may be purchased separately.

 

21 CFR PART 11 TOOLKIT

TRAIN TRACK™ version 8 includes an optional Part 11 Toolkit which provides everything you need for Compliance with 21 CFR Part 11. The toolkit allows you to track changes, control access, and prevent unauthorized changes through password protection, audit trails, and electronic signatures. The Part 11 Toolkit adds all of the following to TRAIN TRACK™:

• Limiting System Access (21 CFR 11.10d)
• Program Time-Outs (21 CFR 11.10d)
• Audit Trails (21 CFR 11.10e)
• Authority Checks (21 CFR 11.10g)
• Electronic Signatures (21 CFR 11, Subpart B)

Database Security

• All programs are password protected
• Unique Login ID's and Passwords are assigned to all users and required for all logins
• Customizable Password Requirements, set by your system administrators
• Multiple Levels of Security allows different parts of your program to be seen or updated by users with the appropriate credentials
• Inactivity lock secures the program after a period of inactivity
  

Audit Trail

• Provides a complete change history for each record:

  • Date of the change
  • User who made the change
  • Old value
  • New value

  
  
• Event Logs record any event that occurs within the program, including logins, log-outs, error messages, or any other event specified by the program
  

Electronic Signatures

The Part 11 Toolkit allows users to secure your data with electronic signatures. The user selects a record, then enters their User ID, password and the meaning of the electronic signature. Once the user confirms the decision to apply the signature, the entry is locked from further editing.

• The electronic signature includes all of the elements required by the FDA:

  • Signature
  • Date
  • The meaning of the signature
    
    
• Records are Locked from being updated once signed
• Adding and remove electronic signatures is captured on the audit trail
  

Search Engine with Customizable Results

• Included Search Engine allows users the ability to search for any records contained within your program.
• Search for any criteria from multiple fields at once.
• Send your search resutls directly to Excel.
• Completely secure.
• View search results in customized reports.
• Ability to save searches and make them available to other users, or keep them private.

Background Information

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

CFR - Code of Federal Regulations Title 21 (FDA Website)

General Principles of Software Validation (FDA Website)

Ofni Systems, Part 11 Toolkit author web site