User Manual

33
An audited solution for
regulated requirements
Processes, requirements, and regulations
may differ in the life science and hospital
industries.
However, there is one thing
both have in common: their envi
ronment
must be safe. With our CMT, we
offer a
compact solution that is audited
for the
strict requirements of the life science
industry. Using a risk-based approach,
it ensures that your GxP-critical environ-
mental parameters are always under
control – whether in your pharmaceutical
production facility or operating room.
Meeting international health
protection regulations
To validate your environment and pro-
cesses, you need to provide documentary
evidence that surrounding conditions
that have a direct impact on product
quality or the health of patients – such as
temperature, humidity, air pressure or
air particles – are optimal at all times.
CMT monitors, records, and stores these
parameters in a tamper-proof manner.
The system also provides secure backup
and archiving functions as well as easy,
safe access to your data. In short: CMT
helps you validate your products, pro-
cesses, and environmental conditions in
compliance with all relevant regulations
of the life science industry.*
Extensive expertise for
efficient validation
We developed CMT on a risk-based
approach, utilizing standardized technolo-
gies. The validation documentation as well
as
the dedicated services are based on
GAMP 5. CMT helps you comply
with legal
specifications and considerably
reduces
your validation efforts. And thanks
to our
comprehensive service offering, CMT
can be optimally implemented in your
environment – whether you are in
the
life science or hospital industry.
Complying with
regulatory requirements
Highlights
■
CMT is audited according to
the strict international regula-
tions of the life science
industry
■
The compact solution is also
the ideal choice for non-regu-
lated environments such as
operating rooms
■
Reliable monitoring, storage,
and archiving of GxP-critical
environmental parameters
■
Low validation costs thanks to
standardized technology
■
CMT is based on many years of
industry-specific expertise
from Siemens
* EU Directive 2003/94/EC on good
manufacturing 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,
Annex 20