Data Sheet for Product

Siemens Industry, Inc.
Page 3 of 5
21 CFR Part 11 Designed Features
The key features of the Desigo CC solution that are
designed to support 21 CFR Part 11 compliance
include:
• Management of Electronic Records – Desigo
CC software provides long-term management and
reporting of key electronic records. These include
trend records, alarm records, system activity
records, and Assisted Treatment operating
procedure records.
• Audit Trails – The Desigo CC software provides
detailed audit trails on data within the Desigo CC
database and automatically records critical
changes to records in the history database. This
makes the Desigo CC database the central place
for reviewing all audit trail information.
• Security – Desigo CC software uses multi-
layered, integrated Windows security to ensure
that the right people have access to the right
information ensuring necessary record access to
all key stakeholders.
• Direct Interface to History Database – provides
a direct, secure, and reliable data exchange
interface between the Desigo CC application and
the history database. This interface reduces
configuration time and provides increased
robustness in the transmission of data to the long-
term data management solution without having to
be logged at an intermediate location.
• Advanced Electronic Records Processing and
Reporting – Desigo CC applications provide a
wide range of report and processing tools to turn
data into information. These include:
− Alarm Summary Table with Chart Report -
Provides detailed alarm event totaling,
average total alarm time in tabular and
graphical summaries
− Summary Statistics Table with MKT Report -
Report designed to show key statistical
summaries including MKT
− Scatter Chart Report – Chart showing the
historical values of one or more objects for a
selected time range
− Multiple Point Trend Data Table Report –
Tabular report showing values of multiple
trended objects compared over a time range
• Enterprise-Wide Access – Desigo CC is
specifically designed such that it can be
personalized for users who might not typically use
the building automation system. Desigo CC also
efficiently distributes information over the existing
enterprise network to stakeholders who need it,
when they need it.
• Archive Management – Desigo CC provides
long-term data management with ability to create
multiple history database volumes that manage
online and offline data so that users can simply
focus on requesting the data they need, not trying
to locate it or reload it. Archiving flexibility ensures
that an archiving strategy can be developed to
meet a wide range of data management needs.
Field Panel Firmware Compliance-based
Features
To ensure that records are protected at their point of
creation and to reduce the need for procedurally based
service modes, the field panel firmware has multiple
technical elements to maximize compliance, including:
• Field Panel Password Expiration and “Three
Strikes” – A Field Panel User Account password
can be set to “never expire” or expire every xx
days, in which “xx” can be anywhere from 1 to 365
days. Additionally, with expiration enabled, users
have only three tries to enter a correct password
prior to being locked out. A lockout requires a
reset by an administrator.
• Trend Sample Synchronization – Time-based
trend samples can all be synchronized to the same
time interval, providing better cause and effect
analysis.
• Network Time Synchronization – The field panel
network time is automatically synchronized to the
Desigo CC Server’s time. In the event that the
server is not on the network, the field panel
network time synchronization uses the time of the
first panel on the network as the time source.
• Buffering – Trend buffering helps to prevent data
loss:
− Firmware provides up to 2500 samples within
the panel. This buffer minimizes the possibility
of trend data loss during a network outage
− Field panels with BACnet firmware should
always be connected on a dedicated secure
network that prevents the possibility of
unauthorized users or devices from making
changes to APOGEE field panel databases
using standard BACnet services.