User Manual

8
CMT is a compact monitoring
solution that helps you gain
and maintain a validated status.
It complies with the strict
regulations of the life science
industry and can be quickly
and easily installed.
8
Streamlining the
validation process
Cost-effective validation
In the life science industry, you have to
assure a high product quality to prevent
jeopardizing the lives of consumers.
CMT is a standardized system that is
pretested to FAT before it is delivered to
your site. In addition, validation docu-
mentation is predefined according to the
GAMP 5 V-model – reducing your valida-
tion expenses and your time to market.
Extensive impact analysis
As part of our service offering, we con-
sider your industry-specific regulations and
examine possible impacts of the building
structure on product quality. Then we use
the risk assessment to analyze with you
which processes and building areas have
to be validated – and thus require moni-
toring using CMT. This makes CMT a cost-
effective monitoring solution. Of course,
you will receive
documented evidence of
the analysis, which is easy to adapt for
submittal to the regulatory authorities.
Maintaining a validated status
We support you with our unique service
program that includes recalibration of
sensors, tests according to 21 CFR Part 11,
and EU GMP guidelines, Annex 11.
Orbis Medical Park,
The Netherlands
GMP-relevant information
on environmental conditions
in the hospital pharmacy
are monitored using CMT:
15 temperature, 8 humidity,
and 9 pressure values are
displayed and archived.
Highlights
■
Lower validation costs and
shorter time to market, as CMT
is preconfigured according
to GAMP 5 V-model
■
Monitoring is limited to critical
processes and building areas
that have to be validated
■
Our comprehensive service
offering supports you in gain-
ing and maintaining a vali-
dated status