DESIGO building automation system

Pharma Solution
Integrated regulatory compliance for
DESIGO INSIGHT
The DESIGO INSIGHT Pharma Solution meets the heightened requirements found
within the tightly regulated Life Science Industry.
The application offers advance technical solutions for customers with high
requirements for IT integration, availability and long-term data security.
Pharma Solution Benefits and Features
• An audit trail at the database level for GxP
critical data prevents unauthorized attempts
to make changes to data in the audit trail,
log, trend and system databases.
• The Viewer application is used to search for
data within the audit trail, to create reports
from the data or backup archive files.
• During a disaster, the hourly backup copies
of all database transaction logs and daily
comprehensive database backups
significantly reduces the potential for data
loss.
• User actions must be justified with a reason
(or comment), before the action is carried out.
• A complex MD5 checksum for each archived
file ensure the integrity of all archived data.
The option to secure the readability of
archived files throughout the entire data lock
out period is guaranteed through the use of
XML as a storage format.
• User administration is simplified through the
use of integrated Windows confirmation
(linking the Windows user to the DESIGO
INSIGHT user).
Extension of DESIGO for the Pharma Solution
Database Audit Viewer
Standard report templates
Comments for user actions
Data integrity using checksum verification
Database Audit Viewer
The Audit Viewer application data makes it possible to scan, search or filter the
audit trail database or any other XML archive file (produced by an existing Pharma
Solution. The application can also be used to generate printable audit reports. The
MD5 checksum is verified when view the archived data and the reports are
included in the report.
55 / 64
Siemens DESIGO Building automation and control system CM110660en_03
Building Technologies
System description