Data Security and 21 CFR part 11?
Once a temperature sample has been taken and stored in the onboard RAM of the
ThermaViewer™ it can not be changed.
The time and temperature display parameters can be changed if the user has the proper password, but the underlying data can not be altered.
When the collected data is downloaded to a computer the TView program creates two saved files if the encrypted flag is set. It saves a 'csv' file which can be loaded into Excel or Notepad and it also saves an identical file in a 'tvx' format. This is an
encrypted file format which can only be read or printed with the TView program. If a previously saved 'tvx' file is loaded into the TView program a small icon appears on the screen indicating that you are viewing encrypted data.
If a 'csv' file is loaded into Excel, Word, Notepad or some other text editor type program it can be manipulated and re saved and even called back up into the TView program. However it will not have the
'locked padlock' icon on the file indicating that it could have been changed. This meets the requirements of US regulation 21 CFR part 11 but the user is expected to take steps to insure that the data files themselves are kept secure in accordance with the measures required under 21 CFR part 11.
Temperature and RH graph as it appears on a computer.
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