Shimadzu TW223L, Instruction Manual, Page: 12 / 158

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Shimadzu Balances and 21 CFR Part 11
21 CFR Part 11
21 CFR Part 11, Electronic Records, Electronic Signatures, Final
Rule (often referred to as Part 11) is the United States Food and Drug
Administration (FDA) regulation affecting computer resources and
electronic records that are used for any document that is required to be
kept and maintained by FDA regulations.
Requirements concerning computer resources security are key
elements in Part 11.
The controls implemented as a result of security related requirements
are intended to result in trusted records.
Shimadzu CLASS-Balance Agent
Shimadzu provides a means for compliance with 21 CFR Part 11 with
Shimadzu CLASS-Balance Agent software, part of a comprehensive
laboratory data management system, Shimadzu CLASS Agent.
Ask your Shimadzu representative about it.
Shimadzu WindowsDirect
When Shimadzu balances are integrated with laboratory software by
means of our WindowsDirect function, no communication software is
required or used.
The Shimadzu balance functions as a primary device in the system,
just as a keyboard, mouse or other data entry hardware does.
For this reason, system validation and compliance may be greatly
simplified with the use of Shimadzu balances.
Two-way Communication
Shimadzu balances have always been computer friendly and they can
be set up for bi-directional communication as part of a fully automated
production system or LIMS.
This manual includes the command codes and information needed by
programmers to integrate Shimadzu balances with their software.