MESA LABORATORIES, INC. DataTrace Division
Standard
Operating
Procedure
Release Date: August 27, 2010
Page: 13 of 32
Revision B
Simple
, in addition to the SHA-1 algorithm, requires that the user login in order to access
the program. Each user is then assigned one of three possible authorization levels: "Data
Only", "Data and Utilities", or "Administrator". These authorization levels allow access
only to those function levels of the program that the user has been approved for. This
security level does not implement data signing or auditing necessary to meet USFDA's 21
CFR Part 11.
Complete
complies with USFDA's 21 CFR Part 11 and, in addition to the password
protection provided with Simple Security, it provides for "Electronic Signatures".
For the two levels of enhanced security available for DTW: “Simple” and “Complete”, the System
Administrator (Administrator) should make the initial installation of the DTW program. The
Administrator assigns passwords and authorization levels and is responsible for system security.
The following provides an overview of the procedures for enabling the secure levels of program
operation.
1. During installation the user selects the level of security that the DataTrace
®
for Windows
will function under. If "Simple" or "Complete" security is to be enabled, the individual that
is assigned the Administrator role should be involved in the installation of the DTW
program.
2. The first time DTW is started following installation with an enhanced security level
designated, the Login screen appears.
3. Enter "admin" as the Login and "admin" as the Password. This is only valid the first time
the program is used following installation, the Password will be changed later.
4. After "admin", "admin" is entered, a dialog box will appear requiring a new Password.
Change the Password as instructed on the dialog box: with a minimum of 8 characters
and at least one of them must be numeric, no spaces.
There will be a delay while the new Password is recorded, encrypted, stored, and
registered.
This is the only Password that will work at the Administrator level. This is important
because the Administrator is the only one that has access to the SETUP tab and assigns
the authorization levels for other users.
5. The SETUP tab, in enhanced security modes includes all of the program configuration
functions plus the USERS Tab. The USERS Tab allows the Administrator to establish
new users. This function is only accessible by the Administrator.
The Administrator adds a user by clicking the Add User button. A dialog box appears
asking for a user Login, the new user’s full name, and authorized security level.
Click the Save button and the new user is added to the Users List. The new user is active
and has access to his/her authorized levels when there is a check mark in the “Active”
check box of their User data.
A user can not be removed from the Users List, only deactivated. A user is deactivated
by removing the check mark from the Active check box.