2 pc evaluation software, 1 general, 2 instruments with fda compliance – JUMO PCA3000 PC Evaluation Software User Manual

Page 11: Pc evaluation software, General, Instruments with fda compliance

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2 PC Evaluation Software

2.1 General

The PC Evaluation software (PCA3000) is used for archiving and evaluating
data (including device audit trail data, if available). In the software, an
electronic signature can be attached to the archived data.

The PCA3000 is on a CD, together with:

- PCA Communications software (PCC),

- Setup software (only for specific instruments) and

- Documentation in the form of PDF files.

2.2 Instruments with FDA compliance

The CD also contains:

- PC Security Manager software (PCS) and

- PC Audit Trail Manager software (PCAT).

For instruments with an increased security level, the software is freely avail-
able on the Internet in “read-only” mode (PCA3000 viewer), for purposes of
FDA inspection and checking.

Anybody who has been authorized by the administrator is allowed to start
and use PCA3000. The administrator uses the PC Security Manager soft-
ware (PCS) to allocate authorizations.

PCA3000 is installed in conjunction with the installation of the PC
Security Manager software (PCS). In this case, the installation will be
different from the installation procedure described in Chapter 3
“Installation”.

H

PCA3000 can be used for data from different instruments.
Differences may occur between the operating manual and
the individual instrument-specific functions.

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