Logtag-recorders LogTag Analyzer Temperature Recorder Manuel d'utilisateur télécharger pdf (Page 83)

Chapter 5 Results from LogTag 83

that the particular block of recordings has only the validation and integrity protection

offered by the communications between the LogTag and the computer system, which

is typically the same, if not better than the level of protection offered by every other

brand of logger available in the global market, that LogTag Recorders know of.

3 A communications or hardware failure has occurred during the transfer of the data

from the LogTag to the computer. In this scenario the problem is typically resolved by

trying to retrieve the recordings from the LogTag again, while ensuring the contacts

on the back of the LogTag are clean, that the contacts within the Interface Cradle are

clean and that the contacts within the Interface Cradle are returning evenly to their

normal position when the LogTag is removed.

Since the software does not modify any of the recorded data within a LogTag file at any

time, if the software can open the file, regardless of how long ago it was created, the

contents of the file will still represent the original recorded information retrieved from the

LogTag.

Therefore, the files created by the LogTag Analyzer software meet all criteria for data

integrity and data security as set forth in the US FDA 21 CFR Part 11 regulations. The

firmware code that is embedded in the processor chip of each LogTag cannot be

extracted or reverse-assembled. Accordingly, data sets that are recorded on the memory

within the LogTag cannot be downloaded or modified except by being transferred to a

LogTag file. There is no way to interfere with the process of the transfer of information

between the LogTag and the software in such a way that data integrity would be

compromised.

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Logtag-recorders LogTag Analyzer Temperature Recorder Manuel d'utilisateur Page 83