User Manual

3
Comply with regulatory requirements
with CMT
International health protection
regulations
European and American authorities de-
fine measures* that must be carried out
to protect public health and safety. One
of these measures involves providing
documentary evidence that environmen-
tal conditions which have a direct impact
on product quality – such as tempera-
ture, humidity, air pressure and particle
measurements – are recorded and saved
in a tamper-proof form. CMT makes it
possible to conduct all relevant measures
efficiently and in compliance with regula-
tions.
Extensive expertise for your
efficient validation
We have developed a solution consisting
of standardized technology and analysis,
validation and service components based
on the experience we have gained in over
1,500 life science projects throughout
the world. The solution makes it easy
to comply with legal specifications and
reduces your validation efforts consid-
erably. Thanks to our comprehensive
services, your CMT solution can be imple-
mented optimally in your environment.
Four steps to a validated solution
– The first step of the CMT solution pro-
vides a pre-qualification service. Our
experts use system analyses to define
environmental parameters critical to
GxP. CMT only needs to monitor these
parameters, which considerably cuts
your monitoring and validation costs.
– In step two, we deliver the technology
– an independent standardized moni-
toring system for critical parameters.
The advantage of this technology is
that it is already pre-engineered, pre-
installed and pre-tested under the
most stringent conditions.
– In the third and fourth steps, we pro-
vide validation services and prepare
measures to ensure you maintain your
validated status even into the future.
International regulations are
met consistently thanks to CMT
Our industry-specific expertise
reduces your validation expenses
considerably
CMT delivers a validated solution
in four steps, cutting your costs
Highlights
* EU Directive 2003/94/EC on good manufactur-
ing practice, Annexes 1, 11, 14 and 15; Section
21 of the US Food and Drug Administration Code
of Federal Regulations, Parts 11, 210, 211, 606
and 820