Beckman Coulter Multisizer 4, Руководство пользователя

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PN A51387A
B
10-2
Regulatory Compliance
Regulatory Compliance
The FDA ruling includes these guidelines:
• The agency emphasizes that these regulations do not require, but rather permit, the use of electronic
records and signatures
. (General comments section)
• The use of electronic records as well as their submissions to FDA is voluntary. (Introduction to final
ruling)
• If electronic submissions are made:
Persons may use electronic records in lieu of paper records or electronic signatures in lieu of
traditional signatures….provided that: (1) The requirements of this part are met; and (2) The document
or parts of a document to be submitted have been identified in public docket No. 92S-0251.
(Section
11.2 subpart A).
Section 11.3 Subpart A describes two classes of systems; closed and open .
• A closed system is one where system access is controlled by persons who are responsible for the
content of electronic records
. The people and organization responsible for creating and
maintaining the information on the system are also responsible for operating and
administering the system.
• An open system is one where system access is not controlled by persons who are responsible for
the content of electronic records.
A typical Multisizer 4 system can be regarded as a closed system.
Security Controls
A Multisizer 4 installation needs to have a procedure designed to ensure proper operation,
maintenance and administration for system security and data integrity. Persons who interact with
the system, from administrators to users, must abide by these procedures. Therefore, the ultimate
responsibility is with the organization generating electronic records and signatures. The Multisizer
4 software is a component, albeit a vital one, of the overall process.
The controls to be applied to a closed system are specified in Subpart B, Section 11.10.
Electronic Controls
The chief purpose of electronic controls is to ensure the authenticity, integrity, and, when appropriate,
the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed
record as not genuine
. Many of the controls described in Section 11.10 refer to written procedures
(SOPs) required by the agency for the purpose of data storage and retrieval, access control, training,
accountability, documentation, record keeping, and change control.
System Validation
Other controls are addressed either by the Multisizer 4 software itself, or in combination with end-
user procedures. Most important is the
validation of systems to ensure accuracy, reliability, consistent
intended performance, and the ability to discern invalid or altered records [Section 11.10 Paragraph (a)].
The complete and overall validation of the system, as developed by the organization, ensures the
integrity of the system and its data. The features of the Multisizer 4 software are designed to comply
with the specifications of these regulations.