User Manual

44
Monitoring and storing
critical parameters
Everything under control
In pharmaceutical production, you have
to reliably protect your products from
contamination – from the raw material
to the finished product. In a hospital,
you have to ensure sterile environmental
conditions, for example in your operating
rooms.
CMT continuously monitors up to
100 critical, GxP-relevant parameters such
as temperature, humidity, air particles,
and air pressure as well as controls access
to
quarantine areas or to sensitive equip-
ment such as a thrombocyte separator.
Reliable sensors for reliable monitoring
Precise, certified sensors continuously
measure all process-critical and quality-
relevant environmental parameters.
In addition, CMT has a built-in sensor re-
calibration warning: the system lets
you know when the sensors have to be
recalibrated. The recalibration cycle can
be set up for each sensor – preventing
complex calibration schedules.
Alarming in case of deviations
CMT alerts you when monitored systems
approach prespecified maximum and mini-
mum values. Should a monitored value
fall short of or exceed the predefined
value, an alarm is immediately triggered.
All reactions to alarms are stored in an
alarm database in compliance with
21 CFR Part 11 and Annex 11.
Data recording and archiving
To comply with monitoring and control
regulations, CMT records all relevant pa-
rameters on an hourly, daily, and weekly
basis. The data is archived in an SQL data-
base for the entire life cycle of a product
or for a defined time period when moni-
toring an operating room, for example.
Creating trends and reports
CMT helps you easily create trends and
reports that contain all relevant data and
information. You can even tailor these
reports for different target groups and add
graphics or statistics for a better overview
and easier evaluation. In addition, you
can track room conditions online, enabling
you to identify quickly and easily whether
they presently comply with specifications.
Highlights
■
Monitoring of up to 100 critical
environmental conditions
■
Precise, certified sensors
continuously monitor process-
critical, quality-relevant
parameters
■
Built-in sensor recalibration
warning
■
Immediate alarming when
threshold
values are reached
■
CMT automatically records and
archives all relevant parameters
■
Easy creation of clearly
arranged trends and reports
■
Multi-user operation for up to
10 remote Web clients
Validalium Testpohl 1 Validalium Testpohl 2
The histogram report
59.00 - 61.80 61.80 - 64.60 64.60 - 67.40 67.40 - 70.20 70.20 - 73.00 73.00 - 75.80 75.80 - 78.80 78.80 - 81.10 81.10 - 84.20 84.20 - 87.00 87.00 - 89.80
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11
0
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