VLD-5EU/5US - FDA 21 CFR Part 11 Compatible Software

Overview
VLD-5EU/5US
T&D Recorder VLD for Windows, the revolutionary software application exclusively designed for use with T&D’s Thermo Recorder RTR-5 Series is complete with the following unprecedented functions: Security (Software Operation Password Protection and Prevention of Data Manipulation via Password) and Recording of Software Operations History (Audit Trail). In order to perform validation and comply with validation standards set out in FDA21 CFR Part 11, these were added to the standard functions of our original software T&D Recorder for Windows, which helps manage recorded measurement data, including the display of recorded temperature and humidity data in graph form.
*Does not include RTR-52Pt and RVR-52A.
FDA21 CFR stands for "Title 21 of the Code of Federal Regulations" concerning control measures and regulations regarding food and drug safety falling under the jurisdiction of the United States Food and Drug Administration (FDA).
"Part 11" which became effective in August, 1997 outlines regulations concerning the FDA requirements for accepting electronic records in lieu of paper records and defines the procedures and controls for ensuring the authenticity, integrity, non-repudiation and confidentiality of electronic records and signatures. A copy of the rule is available at http://www.fda.gov/ora/compliance_ref/part11
Main Validation Functions
  • Automatic Recording of Software Operation History
  • User Registration
  • Save Downloaded Data as Original Encoded File
  • Reprint Exact Same Graph
Basic Functions
  • Confirm Downloaded Data in Graphs and Tables
  • Create Text File for Recorded Data
  • Edit Graph Display Colors and Recording Conditions
  • Efficient Management by Creating Remote Unit Groups
  • Remote Unit Recording Conditions and Data Collector Unit Settings
Compatible Devices
The validation function of T&D Recorder VLD for Windows can be used with the following models.

Data Logger : RTR-51/51A/51L/51AL, RTR-52/52A/52L/52AL, RTR-53/53A/53L/53AL, TR-51A, TR-52
Data Collector : RTR-57U
Related Products
For details about features and functions of RTR-57U, see the following product introduction page.
Important Notice
We cannot sell these products to distributors or consumers in countries other than where the wireless units have been approved for use. If these wireless products are used outside of the designated areas of Europe, Oceania, and the Americas where the devices have been granted approval, T&D Corporation shall in no manner whatsoever take responsibility for the usage of these products, nor be liable in any manner for legal consequences stemming from the usage of these wireless products in unapproved areas.