Beckman Coulter Multisizer 4, User Manual

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PN A51387A
B
10-3
Regulatory Compliance
File History and Audit Trail
10
The Multisizer 4 software employs a system of usernames and passwords, consistent with the
specifications of Subpart C, Section 11.300,
to ensure that only authorized individuals can use the
system, electronically sign a record, access the operation or computer system input or output device, alter
a record, or perform the operation at hand
.
Audit Trail
The Multisizer 4 software performs data input and operational checks that
determine, as appropriate,
the validity of the source of data input or operational instruction, and enforce permitted sequencing of
steps and events
(Subpart B, Section 11.10). These two features ensure that, as much as possible, valid
data are entered into the system, and all required steps have been completed to perform the task at
hand.
The purpose of all such data checking and validation is to allow the system
to generate accurate and
complete copies of records in both human-readable and electronic form suitable for inspection, review, and
copying by the agency
[Section 11.10, Paragraph (b)]. The Multisizer 4 software system is able to
enforce strict procedures to record all changes that are made to data generated using the software
[Section 11.10, Paragraph (e)]. See
File History and Audit Trail
, page 10-3 .
File History and Audit Trail
File History or auditing can be enabled for any file created by the Multisizer 4 software. After
auditing has been enabled for a file, it cannot be disabled, nor can it be bypassed. Under these
conditions, all changes made to a file are automatically recorded. These changes consist of
computer-generated, time-stamped audit trails to independently record the data and time of operator
entries and actions that create, modify, or delete electronic records
.
When a change to a file is detected, the Multisizer 4 software automatically records the identity of
the user making the change, the date and timestamp of the change, the parameter that has changed,
the old value and the new value. The user is also required to “re-sign” the record electronically and
enter a reason for the change, from a pre-defined list or as free text.
The audit trail is stored as File History inside the file itself, so that record changes shall not obscure
previously recorded information , and so the file is suitable for inspection, review, and copying by the
agency . This ensures that a complete and continuous record of all changes to the file is maintained.
The file protection and archiving capabilities of the Multisizer 4 software ensure compliance with
the requirement that
audit trail documentation shall be retained for a period at least as long as that
required for the subject electronic records [Section 11.10, Paragraph (e)].
Accessing File History
To access the File History:
1.
Select
File > Open
on the Main Menu bar and navigate to the file you want to open.
2. Select
RunFile > Get File History
on the Run Menu bar. The File History window opens.
3.
Click
(
Close
)
to exit the window.