Beckman Coulter FP 1000, Руководство пользователя, Страница: 39 / 52

PN 623112BA
B-1
B B
21 CFR PART 11 REGULATION SUPPORT TOOLS
B.1 OVERVIEW
The FDA’s Electronic Records and Electronic Signatures Rule (21 CFR Part 11) outlines the
requirements for submitting documentation in electronic form and the criteria for approved
electronic signatures. It defines the standards by which an organization can use electronic
records to meet its record-keeping requirements.
Implementation and compliance of 21 CFR Part 11 is the responsibility of the laboratory
creating and signing the electronic records. Proper laboratory procedures and key features of
the FP 1000 as described in this section can be used to achieve compliance with this
regulation.
The FP 1000 is a closed system per the definition stated in Section 11.3, Subpart A of the
regulation: Closed System - environment in which system access is controlled by persons
responsible for the content of electronic records on the system.
All FP 1000 users in your laboratory must be trained to properly and consistently use your
laboratory’s procedures regarding electronic records and signatures.
B.2 INTEGRITY OF ELECTRONIC DATA
The division of Beckman Coulter that produces the FP 1000 uses quality-controlled,
validated development and manufacturing processes. Beckman Coulter, Inc. is certified as
ISO:9001:1994- and ISO 13485-compliant.
Passwords
All user accounts must be password- or activity-controlled.
Perform your procedures for creating and maintaining passwords. Be sure to include these
criteria in your procedures:
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Administrator password
FP 1000 software provides this capability.
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Unique user ID/password combination
FP 1000 software provides this capability.
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When (how often) the password needs to be changed by each user
FP 1000 software provides this capability.
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Maintenance of a history file of each new and deleted user, and modified user IDs. The
person’s full name, the user ID, any name change by the person (such as after marriage),
and a brief history of instrument access (such as start and end dates).
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There is to be no unauthorized use of another user’s ID or password.