Brochure

4
Step 1:
Service
Step 2:
Technical solution
Step 3:
Validation
Step 4:
Service
Service – identifying your quality-relevant
environmental parameters
Based on our expertise, we offer competent impact analysis and risk assessment
support to identify your critical environmental parameters.
Highlights
Identify critical components within
your production environment
through comprehensive analyses
Reduce costs and validation expenses
by minimizing parameters that require
monitoring
Identify efficient measures to
minimize risks
Create documents for submission
to regulatory authorities
Improved product quality thanks to
a comprehensive risk assessment
Our experts, a system representative and
your quality assurance department work
together to assess the various risks that
may arise throughout the system‘s life
cycle. CMT monitors and identifies critical
parameters to minimize risks to your sys-
tem and keep your validation expenses as
low as possible over the long term.
Reduced costs thanks to extensive
impact analysis
Our experts help you create a compre-
hensive impact analysis of your building
infrastructure. The analysis categorizes
building infrastructure systems according
to their impact on product quality. This
differentiation clearly identifies which
systems require validation and monitor-
ing using CMT. As a result, only your CMT
needs to be validated, which reduces
your validation costs considerably.
You also receive documented evidence
of the analysis, which is easy to adapt for
submital to the regulatory authorities.
CMT – four steps to a solution
Step 1:
Service
Step 2:
Technical solution
Step 3:
Validation
Step 4:
Service
Impact analysis
and risk
assessment
Data conversion
and storage
for trending
and reporting
Validated solution Maintain validated
status
Backup and archiving
functions
Fast compilation and
easy access to data
IT security
Physical
security