16 Using Special Functions
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All audit trail entries that have already been exported are deleted.
For data safety reasons, it is not possible to delete audit trail entries that
have not been exported before.
Verifying the integrity of audit trail exports
Audit trail data exports are protected by a MD5 checksum file that is exported
together with the data file to guarantee full traceability.
After successful export of the data file and the corresponding md5 file, a new audit
trail entry including the MD5 checksum (hash) is generated. This checksum can
be compared with the checksum of the exported file at any time to confirm that the
exported file was not manipulated.
To generate an MD5 checksum
Any MD5 checksum program can be used.
Example: Using the program "md5summer.exe" that can freely be downloaded
from www.md5summer.org/download.html.
1. On your PC, start "md5summer.exe".
2. When asked "please select the root folder", select the directory where the log
files (the .md5 file and .xls or .txt file) are saved and click <Verify sums>.
3. In the following dialog, select the .md5 file that you want to check and click
<Open>.
The check status and result are displayed.
If the checksum (hash) is the same as in the corresponding DMA M audit trail
entry, the export file has not been manipulated.
4. Quit the program by clicking on <Close>.
16.1.5
Electronic Signature
Electronic signatures can be classified as ordinary manual signatures to help
within the authenticity of electronic data in regulated process environments.
Roles for the electronic signature
Depending on importance or impact, different signing roles can be assigned to a
user. According to common regulations, you can choose between three different
roles: submitter, reviewer or approver.
Once the electronic signature function has been activated, a sample can be
signed as positive or negative by the submitter, followed by the reviewer and
finally by the approver. If a user of a higher level signs first, the signing states of
the lower levels are set according to the evaluation of this higher level user.
