Comark EV SOFTWARE - Manual (Page 20)

19
Standard Operating Procedures (SOPs) - Guidelines and rules defined by the
organisation implementing Title 21 CFR Part11 compliance to instruct users what they
are and are not permitted to do and how they are to perform the relevant tasks.
EV Professional Software - The EV Professional Software includes a number of settings
and data protection devices that, when used with with the EV, EVG and EVt series
of data loggers, will give the user a compliant system if adopted into their SOPs. The
software can control the access to areas of the software by individual user by means of
Administrators who can set up and allocate individual users with their own unique access
levels to the software. However it is always the responsibiltiy of the organisation to make
sure that any particular user is responsible and understands that any document he/she
signs using this software under a 21 CFR environment is the equivalent of a handwritten
signature. It is important that you enter the information into these two boxes that will
provide the correct amount of information for future viewers of the task.
12.3 Electronic Signatures (EV Pro Only)
To be compliant with the requirements of 21 CFR Part 11 Electronic Signatures have
been added to the EV Pro software.
When deciding when to sign a task it is important to remember what state the task is in
before signing and there are a number of rules that need to be recognised before signing
should take place:
Any task that is signed will be closed.
When a task is closed there may still be a logger that has yet to be docked and have
data downloaded. The consequence of this is that the data from that logger will no longer
be associated with this task, but will have a new task assigned that is deemed to be
externally created.
Once a task has been signed it cannot be modified in any way. Users must accept the
current graph settings for this task as they cannot be changed once the task is signed.
This includes the task description.
A signed task will include both the name of the signer and an encryption code which
will be stored with the task. This allows anyone to know that the task has been signed
correctly. This is particularly important when emailing archive databases to another user.
The code can only be recognised by other users with the Pro version of the software. It
allows another user to be sure that the task was properly signed.
Users must ensure that the task they select to sign is the correct one, because once a
task has been signed it is saved as a unique record and cannot be changed.