1 Introduction
6
1.2 Arrangement of the documentation
The documentation for this instrument is addressed to equipment
manufacturers (OEMs) and users with appropriate technical expertise. It
consists of the following parts:
Sales documentation in the form of PDF files
White Paper
The JUMO White Paper presents the company's position on the regulation “21
CFR Part 11” of the American health authority FDA (Food and Drug
Administration). With each section of the regulatory text, the user is given
information on the fulfillment of the requirements.
Product
description
The product description illustrates the security and operating concepts behind
the system, and the results that can be achieved by JUMO in the course of
validation of an installation. It is intended to serve as an introduction to the
system, and not as a formal technical document.
Instrument documentation in printed form
B 95.5011.1
Operating Instructions
The operating instructions are an extract from the operating manual and cover
the basic operation of the paperless recorder.
B 95.5011.4
Installation Instructions
The installation instructions describe the installation of the recorder and the
connection of the supply and signal cables. The instructions also contain a list
of the technical data.
Instrument documentation in the form of PDF files
The “Instrument documentation in the form of PDF files” is on the CD that
comes with the delivery.
B 95.5011.0
Operating Manual
It contains information about commissioning, operation and parameterization
on the instrument, as well as about the PC setup program (available as an
option).
B 95.5011.1
Operating Instructions
The operating instructions are an extract from the operating manual and cover
the basic operation of the paperless recorder.
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