Beckman Coulter LS 13 320, User Manual

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PN B05577AC 4-5
Regulatory Compliance - 21 CFR Part 11
Electronic Record Control - 21 CFR Part 11
4
Generating Electronic Signatures
The LS 13 320 software employs User ID's and passwords to verify the identification of each user
logging into the system. When using this technique, requires maintaining the uniqueness of each
combined identification code and password, ensuring that no two individuals have the same
combination of identification code and password. This section also requires that identification code
and password issuance are periodically checked, recalled, or revised. The LS 13 320 software satisfies
both of these requirements.
The administration of the system requires that individuals are added to the list of valid LS 13 320
users via the Add a User Account dialog screen. The identification code or user name of each
LS 13 320 user must be unique. No two users on the same LS 13 320 system can have the same user
name. It is also required that users, supply a password to access the LS 13 320 software, thus
satisfying the requirement of employing at least two distinct identification components,
identification code and password. Passwords can be controlled to prohibit the use of duplicates and
to force the selection of new passwords after a prescribed period of time.
By the implementation of these features, the LS 13 320 software can satisfy the requirement that,
identification code and password issuance are periodically checked, recalled, or revised.
Users may be authorized to generate electronic signatures by the administrator via the User
Privileges dialog box. When a user has been authorized, he/she can electronically sign a file.
To generate the electronic signature:
1
From an open file, click
Edit
.
2
Click
Add Electronic Signature
. The Add Electronic Signature dialog box displays.
3
Enter your password and select a meaning from the Meaning drop down list.
4
Click
Save File
.