Beckman Coulter Multisizer 4, User Manual

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PN A51387A
B
10-6
Regulatory Compliance
Maintaining Electronic Signatures
To authorize a user type to generate electronic signatures:
1. Open the Multisizer 4 software and log in using an Administrator account.
2. Select
Administrator > User Privileges
on the Main Menu bar.
3. In the User Privileges window, select Can add an Electronic Signature. The checkboxes are
aligned in five columns corresponding to user types.
4. Click
(
OK
)
.
To generate an electronic signature:
1. Select
File > Open
on the Main Menu bar and navigate to the file you want to open.
2. Select
Edit > Add Electronic Signature
on the Run Menu bar. The Add Electronic Signature
window opens.
3. In the Add Electronic Signature window, enter your password and select a meaning you
previously recorded.
4. Click
(
OK
)
.
Applying Electronic Signatures
Subpart C, Section 11.200 stipulates several requirements for the control of electronic signatures.
The regulations require that electronic signatures be used only by their genuine owners, and that
signatures are administered and executed to ensure that attempted use of an individual’s electronic
signature by anyone other than the genuine owner
requires collaboration of two or more individuals .
Through the application of Multisizer 4 user and password configuration procedures, the system
can be configured to ensure that use of these identifiers by someone other than the owner can be
performed only with the owners permission.
Section 11.200 further specifies the use of electronic signature components during a period
when an
individual executes a series of signings during a single, continuous period of controlled system access, and
when an individual executes one or more signings not performed during a single, continuous period of
controlled system access
. This section of the document represents the “heart” of electronic signature
application. To comply with these provisions, the Multisizer 4 software uses the application of the
username and password to authenticate the user making and saving the changes, in conjunction
with file history and audit trails,
to independently record the date and time of operator entries and
actions that create, modify, or delete electronic records .