|
|
|
|
A prerequisite for the validation of a repro-ducible production process is the qualification of the entire system, documenting evidence that all equipment meet the relevant GMP standards as well as customer specifications and that they have been tested accordingly.
No one is as familiar with their equipment as
the original manufacturer. No one can put the machines to the test the way Seidenader can, because we were the ones that designed and manufactured them.
For this task, Seidenader has a competent team of trained specialists who develop customized test plans and 
qualification protocols along with our clients, ensuring their involvement in the development process even in its earliest stages. This also aims at reducing training time and averting last minute surprises in the follow-ing stages of the projects.
All qualification documents are designed in accordance with the cGMP guidelines, the relevant GAMP standards , DIN EN ISO 9001 and recommendations by the FDA.
The documentation can be composed and
adapted specifically to the clients format.
Validation execution time can be reduced,
because the customer is familiar with the
equipment
Reduction of time for training and line
start up – due to the customer being part
of the development and design process
Perfect cost control due to fixed prices for
qualification packages, incl support
for execution
In order to assert our commitment to achiev-ing the highest levels of quality, the quality assurance system designed by Seidenader has been certified according to the DIN EN ISO 9001 standards.
Annual audits by TÜV-CERT and internal audits ensure that the quality system is moni-tored and improved wherever the necessity arises. These quality standards for our machines help you reach the highest levels of excellence in productivity and performance in your production lines.
Validation / Documentation
DQ / IQ / OQ
Spare Parts / Service
Customer Support
---------------------
back
