User Manual
Step 1:
Service
Step 2:
Technical solution
Step 3:
Validation
Step 4:
Service
V-model according to GAMP 5
7
Cut your validation costs thanks
to CMT
CMT has been pre-configured according
to the GAMP 5 V-model, which reduces
your validation expenses. As a GMP
monitoring system, CMT is validated
specifically for each project according
to GMP guidelines.
Pre-defined CMT validation
documentation for faster project
implementation
CMT has been pre-configured and tested
based on the following documents:
– User Requirements Specification (URS)
– Functional Specification (FS)
– Software Design Specification (SDS)
– Factory Acceptance Test Specification
(FATS)
– Traceability Matrix
As experts in the field, we install CMT
on site according to the following stand-
ard documents:
– Site Acceptance Test Specification
(SATS)
– Configuration Management Plan
(CMP)
– Traceability Matrix
– Verification (IQ, OQ)
– Standard Operation Procedure (SOP)
We can customize the documents to your
specific needs as required.
Training for system users
We offer a comprehensive training pro-
gram as well as the necessary standard
operating procedures (SOPs) that ensure
simple and safe operation of your CMT.
Validation – faster validation,
better quality
The pre-tested CMT solution, which is pre-documented according to the GAMP 5
V-model, considerably streamlines your validation work.
Highlights
Lower validation costs since the
solution is pre-configured according
to the V-model
Fast project implementation and
short time to market thanks to pre-
defined validation documentation
Compliance with all regulations
with significantly less validation
effort
Readily accepted in the life science
industry
User Requirements
Specification
Requirements Testing
Functional Specification Functional Testing
Configuration Specification Configuration Testing
Configured Product
CMT
Configurable Product
Siemens
QMS
Initial Risk
Assessment
GAMP 5
IQ/OQ phase
reduced
Functional Risk
Assessment
Initial Risk
Assessment
GAMP 5
Risk-based
approach
Functional Risk
Assessment