VLD-5WEU/5WUS - FDA 21 CFR Part 11 Compatible Software
Overview
RTR-5W VLD for Windows, the software application is complete with the following functions: Security (Software Operation Password Protection and Prevention of Data Manipulation via Password), Encrypted and Password Protected Data Files 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 RTR-5W for Windows.
NOTE: This software cannot be used with RVR-52 / 52A units.
NOTE: This software cannot be used with RVR-52 / 52A units.
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
"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 Functions Complying with FDA 21 CFR Part 11
- User Registration
- Save Downloaded Data as Encrypted Thermo Recorder File
- Automatic Recording of Software Operation History
- Reprint Exact Same Graph
Basic Functions
- Make Settings for Controlling an RTR-5W by a PC over a network
- Efficient Management by Creating Remote Unit / Repeater Groups
- Easily Interpret Data in colorful Graphs and Tables
- Export Data to be Saved or Printed
Compatible Devices
The validation function of RTR-5W VLD for Windows can be used with the following models.
Data Logger (Remote Unit):
RTR-51/51A/51L/51AL, RTR-52/52A/52L/52AL, RTR-52Pt/52PtL, RTR-53/53A/53L/53AL
Communication Port (Repeater): RTR-50
Base Station (Base Unit): RTR-5W
Data Logger (Remote Unit):
RTR-51/51A/51L/51AL, RTR-52/52A/52L/52AL, RTR-52Pt/52PtL, RTR-53/53A/53L/53AL
Communication Port (Repeater): RTR-50
Base Station (Base Unit): RTR-5W
Related Products
For details about features and functions of RTR-5W, 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.