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| Qualification |
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Valicare
offers GMP compliant qualification documents and test
execution. We prepare client specific protocols that are tailored to your
specific needs as a company, your specific process, and your
specific process risks.
Design Qualification (DQ)
– Valicare prepares a DQ that defines all required
functions and unit operations of the desired machine or
process and makes sure that the relevant supplier documents
describing the design meet the specifications.
User Requirements Specification (URS)
– a Valicare prepared URS categorically list all of your
specific project requirements and establishes traceability,
item-by-item.
Installation Qualification (IQ)
– we approach the IQ by writing IQ protocols that address
the specifications for process relevant components as well
as the interfaces to utility systems and other systems and
installations. Then we execute IQ testing using our experienced field personnel.
All measuring equipment used is qualified and
calibrated and is compliant with international requirements
for instruments. Relevant raw data are documented comprehensively and analysed for
compliance.
Operational Qualification (OQ)
– our OQ protocols are written to test the critical system
functions. Testing will cover systems functionality, operation, and required
system safety. By OQ completion we are able to deliver the documented evidence
that your manufacturing equipment is functioning according
to defined acceptance criteria.
Performance Qualification (PQ)
– the PQ protocols define the required performance
criteria and tests certify they are met. During PQ testing we document the evidence that your
equipment is able to perform under routine and even
worst-case conditions. PQ testing demonstrates that different systems are
able to perform correctly “in line” and represents the
documented success of your manufacturing equipment
performing as an integrated system.
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