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Over recent years, Glatt has gradually extended its qualification and validation activities. Our experience can prove invaluable in your risk assessment, when drawing up your validation master plan, and for all other validation-related activities.
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We offer a complete facility qualification service.
From the DQ, IQ, OQ through to the PQ phase.
Partial qualification is also possible on request.
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Risk assessment and validation master plan
If required we can assist you with process validation.
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Restrospectively too.
We will naturally be pleased to validate your existing facilities. |
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Documentation of implemented installations.
Taking into account EC-Guide, GAMP 4, 21 CFR Part II...
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▶ We offer a complete facility qualification service
Glatt defines qualification as the in-project documentation of relevant
quality activities, i.e. documentation firmly anchored in the project itself.
Our success has shown us to be right. With its professional and
practically-oriented approach, Glatt turns qualification into a target-oriented
process rather than a "never-ending story". We work in line with the principles
of GMP. The Glatt control system "MegaView", for instance, was developed on the
basis of the GAMP4 life cycle. And it goes without saying that Glatt control
systems comply with the requirements of 21 CFR part 11.
Glatt offers a variety of different qualification packages for different
requirements. You decide which resources you wish to invest in qualification or
validation, and the degree to which you require our support
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Belt speed measurement
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Press force measurement
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Calibration technician
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Our calibrations are performed using measuring devices checked annually for
their accuracy
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