Comark EV User Manual

EV SOFTWARE
INSTALLATION AND TRAINING
QUICK REFERENCE GUIDE
Contents
1.0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
1.1 Explanation of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.0 Installing the Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1 EV Standard Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.2 EV Pro Software .....................................................3
2.2.1 Daily Password ..............................................3
2.2.2 Installing EV PRO software .....................................6
2.2.3 Adding First Administrator (Super User) ...........................6
2.2.4 Creating/Editing/Changing Users/New Users/Administrators ...........7
3.0 Getting Started/Using the EV software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.1 EV Icons ...........................................................8
3.2 Introducing a logger for the rst time .....................................9
4.1 Quick Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.2 Completing the task form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.2.1 General Setup ..............................................11
5.0 Programming tasks to Loggers .............................................11
5.1 After a task has been programmed ......................................11
6.1 Manual Start/Stop Modes EV and EVt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
6.1.1 Delayed Start (EVt Only) ......................................12
6.2 Automatic Start/Stop Modes EV and EVt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
7.1 Important Note regards EV Pro and 21 CFR Part 11 . . . . . . . . . . . . . . . . . . . . . . . .13
10.1 Database Description ...............................................13
10.2 Editing Tasks/Sessions ..............................................14
10.3 Task Useful Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
10.4 Filtering/Sorting Tasks/Sessions .......................................15
10.5 Filter Recall .......................................................17
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11.0 Mean Kinetic Temperature/Lethality/Pasteurisation
12.1 What is 21 CFR Part 11? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
12.2 Title 21 CFR Denitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .18
12.3 Electronic Signatures (EV Pro Only) ....................................19
12.4 Audit Trails (EV Pro Only) ............................................20
12.5 21 CFR Part 11 Policy Statement ......................................21
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1.0 Introduction
This guide is intended as a quick start guide for the EV software. It covers the basics of programming and data retrieval. Please refer to the main manual, which is included
electronically with the software as a PDF le in "Help-User Guide", for more comprehensive
instructions.
1.1 Explanation of Terms
Throughout this manual the following terms are used for clarity:
User = anyone who uses the software for programming and retrieving data from the EV range of loggers
Administrator = the user who has been designated to authorise other users or administrators.
Super User = An administrator whose password does not expire.
ICONS = Primary EV software functions.
Tasks = A series of instructions for a logger in order for that logger to perform a logging
duty.
Dock = The term used in the software to refer to the interface or cradle for the logger.
Session = A time period of data downloaded from a logger.
2.0 Installing the Software
2.1 For EV Standard software, follow these instructions:
Place the CD into the CD Drive on the PC and allow the software to install automatically.
Once installed Select: Start > Programs > EV Standard > EV to run the software.
Refer to section 3.0 of this guide ‘Getting Started/Using the EV software’.
2.2 For EV Pro Software, follow these instructions:
2.2.1 Daily Password
The EV Pro version of the software is password protected. In order to install
the software for the rst time the user must obtain a daily password from the
Comark Support website. The following information will be needed:
User name and company details including user's e-mail address and a
password chosen by the user.
The serial number from the CD itself. This is a 5 digit number prexed
with the letters WO with a forward slash followed by another number of 1 or 2 digits, e.g. WO12345/67.
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Note : Please ensure when entering the serial number that the letters ‘WO’ are added in front of the serial number if these are not shown on the CD.
Now visit the Comark website: www.comarksupport.com
The following image will appear:
Select Register and type the required information into the following screen:
Check the information entered and then select ‘Submit’ to conrm registration.
Note: Please be careful when entering the user's e-mail address as this will become the user ID.
After registration, the user will need to login. To do so:
Select login from the menu and enter the user name and password into the boxes provided.
After entering the user ID and password the software can be registered and the daily password will be supplied.
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Select Register EV Pro software from the menu options.
Enter the number of copies of the software to be registered and select GO.
Enter today's date to obtain the daily password. The full serial number
e.g. WO12345/67 must be entered. Check the information entered and then select submit.
Note : Please ensure that you add ‘WO’ in front of the serial number if these are not shown on the CD.
The website will then supply the password for the current day, e.g. EV12345.
Important : Write this password down and then log out of the website.
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2.2.2 Installing EV PRO software
Insert the CDROM into the PC disc drive and let the software self-install.
When the software has installed select:
Start > Programs > EV Professional > EV Pro
to run the software.
At this point a password must be entered.
Enter the EV daily password obtained from the Internet and select OK.
2.2.3 Adding First Administrator (Super User)
At this stage of EV Pro software installation it is necessary to add the First
Administrator, who must be a "Super User", to the system
In order to add the First Administrator click on the ‘New User’ Icon -
see below.
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The user name must be entered into the name box. Note: The system will not allow two users with the same name. Also, the user name cannot be changed after it has been used to create a task.
The First Administrator must be a Super User. It is recommended that when entering passwords for all users they are at least 8 characters long and contain alphanumeric characters.
Press OK to nish.
The new First Administrator will be required to log on to the software by entering his/her new password in the box shown.
The user will now be logged on to the software as a new administrator.
2.2.4 Creating/Editing/Changing Users/New Users/Administra­tors
Adding more new Users or Administrators is very simple. The First
Administrator must select Edit > Edit Systems > Users and re-enter his/her
password and click on OK.
The System Users setup screen will be displayed:
To set up a new user/administrator click on the ‘New User’ Icon.
Enter the name required and select the individual features from the list that the new user will be allowed to access.
The new user can now use the software.
Please refer to the Quick Reference Guide section 3.0 Getting Started/Using the EV software.
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