Beckman Coulter Multisizer 4, Руководство пользователя

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PN A51387A
B
10-1
CHAPTER 10
Regulatory Compliance
Regulatory Compliance
Electronic Signatures (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. Organizations that choose to use electronic records to meet record-
keeping requirements must comply with 21 CFR Part 11, which is intended to improve an
organization’s quality control while preserving the FDA’s charter to protect the public. Because
analytical instrument systems such as the Multisizer™ 4 generate electronic records, these systems
must comply with the Electronic Records Rule.
This section describes the relevant portions of the 21 CFR Part 11 regulations and their
implementation using the Multisizer 4 control software. For more information, see
Maintaining
Electronic Signatures , page 10-5 .
NOTE
It is important to realize that implementation and compliance of the rule remains the responsibility
of the organization or entity creating and signing the electronic records in question. Proper
procedures and practices, such as GLP and cGMP, are as much part of overall compliance with these
regulations as are the features of the Multisizer 4 control software.
Electronic Records
Electronic record refers to any combination of text, graphics, data, audio, pictorial, or other
information representation in digital form that is created, modified, maintained, archived,
retrieved or distributed by a computer system. This definition applies to any digital computer file
submitted to the agency, or any information not submitted but which is necessary to be maintained.
Public docket No 92S-0251 of the Federal Register (Vol.62, No 54) identifies the types of documents
acceptable for submission in electronic form and where such submissions may be made.
FDA Requirements
The Multisizer 4 control software has been designed to allow users to comply to the electronic
records and signatures rule. Any organization deciding to employ electronic signatures must
declare to the FDA their intention to do so.