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A chain is only as strong
as its weakest link - this is especially true for very
complex plant that consists of many individual and high-quality
parts. This is why the qualified manufacturing of those
parts is so important.
Our Offer
We actively advise and support you in:
- The selection of manufacturers
- The evaluation of manufactures
- Factory Acceptance Tests (FAT) at the
manufacturer's location
- Site Acceptance Tests (SAT)
Our Procedure
You can especially benefit from our many years of experience
in the selection of qualified manufactures. We can audit
both renowned and newly selected suppliers on our own
or together with you.
Based on a checklist developed over many
years we investigate all of the requirements demanded
of a manufacturer with respect to a GMP related plant,
especially his ability to be used in the qualification
of the individual pieces. At the same time we also clarify
how to integrate the manufactures qualification documents
into your general plant qualification concept.
Before critical pieces of equipment are
delivered to your site we also, upon request, inspect
these at the manufacturer's location within the framework
of FAT, to see whether the quality-relevant requirements,
as defined within the technical specification, have
been met and to ensure correct manufacturer documentation,
which is an important part of the general qualification
documentation.
Upon request, we will also be present during
the quality checks at the point of erection (SAT) when
the pieces are delivered to your site to ensure that
no mistakes occur during this phase that could negatively
influence quality.
Your Result
Qualified and audited manufacturers. FAT and SAT as
part of the general plant qualification. High quality
and inspected plant components
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Consulting
