Beckman Coulter LS 13 320, User Manual

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PN B05577AC 4-1
CHAPTER 4
Regulatory Compliance - 21 CFR Part 11
The Electronic Records and Electronic Signatures Rule (21 CFR Part 11) was established by the FDA
to define the requirements for submitting documentation in electronic form and the criteria for
approved electronic signatures. This rule, in effect since August 20, 1997, does not stand in isolation;
it defines the standards by which an organization can use electronic records to meet its record-
keeping requirements. Organizations that choose to use electronic records must comply with 21
CFR Part 11. It is intended to improve an organization's quality control while preserving the FDA's
charter to protect the public. Since analytical instrument systems such as the LS 13 320 generate
electronic records, these systems must comply with the Electronic Records and Electronic
Signatures Rule.
NOTE
This chapter applies to the compliant version of the LS 13 320 software only.
Electronic Record Control - 21 CFR Part 11
The LS 13 320 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.
File Historyand Tracking
The LS 13 320 software also performs data input and operational checks to ensure that valid data is
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 allows for strict procedural enforcement
within the LS 13 320 software system, recording all changes that are made to data generated from
within LS 13 320 software.
File History is enabled for any file created by the LS 13 320 software in 21 CFR Security mode. 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 LS 13 320 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 “sign” the record electronically and enter a reason for
the change.
The audit trail is stored as History Tracking inside the file itself, so that record changes do not
obscure previously recorded information and 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 user is also required to “re-sign” the record electronically and enter a reason for
the change. Through the file protection and archiving capabilities of the LS 13 320 software, it can