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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 ele-
ments in Part 11.
The controls implemented as a result of security related require-
ments 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 compre-
hensive 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 auto-
mated production system or LIMS.
This manual includes the command codes and information needed
by programmers to integrate Shimadzu balances with their software.
Shimadzu Balances and 21 CFR Part 11
