CAS CAU Series, Owner'S Manual

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CAS 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.
CAS CLASS-Balance Agent
CAS provides a means for compliance with 21 CFR Part 11
with CAS CLASS-Balance Agent software, part of a comprehensive
laboratory data management system, CAS CLASS Agent.
Ask your CAS representative about it.
CAS WindowsDirect
When CAS balances are integrated with laboratory software by
means of our WindowsDirect function, no communication software is required
or used.
The CAS 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 CAS balances.
Two-way Communication
CAS 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 CAS balances with their software.