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MicroStation System, MicroLog Version 4.2 - DTU Systems Biology ...

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8. Administration and Security<br />

In this section:<br />

� What Is Restricted<br />

Access Mode?<br />

� First Log-In and<br />

Setting Up an<br />

Administrator<br />

� Administrator<br />

Options<br />

� Viewing the Log-In<br />

Log<br />

� Changing or Lost<br />

Passwords<br />

� Unauthorized Log-<br />

In Attempts<br />

Administration and Security<br />

The software runs in Restricted or Unrestricted Access Mode, a term<br />

that may be familiar from experience with the OmniLog® <strong>System</strong>.<br />

Let's review what Restricted Access Mode does and why it is<br />

important.<br />

What is Restricted Access Mode?<br />

Restricted Access Mode requires that only users with Administrator<br />

privileges have the ability to oversee and control access to the<br />

software.<br />

The Administrator will:<br />

• Assign Usernames and passwords for those who will use the<br />

system.<br />

• Assign access privileges to each user.<br />

• Oversee the security of the system<br />

Restricted Access Mode requires all users to Log-In with a Username<br />

and password when entering the software or changing users. The<br />

software maintains files of the User List, Log-In Log and Log-In<br />

Log Archive to keep track of registered users, access privileges, and<br />

Log-In/out activity in the system.<br />

All of these files are encrypted. The Log-In Log Archive files can be<br />

placed by the Administrator in the computer/network location of their<br />

choosing. This allows the Administrator to place the files in a location<br />

that has secured access.<br />

Why Restricted Access Mode?<br />

Restricted Access Mode ensures that data integrity and security<br />

controls are implemented in accordance with the guidelines of 21 CFR<br />

Part 11. It assists in compliance with federal Current Good<br />

Manufacturing Practices (cGMP) by ensuring the integrity of software<br />

use and electronic files.<br />

Security Features:<br />

• User List and Log-in Log<br />

• Notification of failed Log-In attempts<br />

<strong>MicroStation</strong> <strong>System</strong>/<strong>MicroLog</strong> User Guide Apr 07 Section 8 � Page 1

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