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Here
are some answers to questions we are frequently asked in relation to
v:kit
Question:
Who can qualify analytical instruments, is it true that only the
instrument vendors should perform operational qualification (OQ)?
Answer:
The equipment user has the ultimate responsibility for the equipment
qualification. This does not mean that the user must perform the OQ,
although there is no technical reason why they cannot. If the user
chooses to have the OQ delivered by either by a service provider or the
instrument vendor then it is their responsibility to ensure that the
quality of the qualifications and importantly their consistency across
instruments are adequate.
Question:
Has v:kit been approved by the FDA or any other regulatory authority?
Answer:
Regulatory authorities do not approve qualification products like v:kit.
What the FDA and other have done is audit pharmaceutical laboratories
that use v:kit for their HPLC and GC qualifications. To our knowledge
none of these audits have resulted in any negative comments on v:kit and
the qualifications delivered with it.
Question:
Are v:tools (the qualification tools available as part of the v:kit
range) NIST traceable?
Answer:
v:tools are are supplied with UKAS traceable calibrations. UKAS (the
United Kingdom Accreditation Service) and the NIST National Voluntary
Laboratory Accreditation Program (NVLAP) are both signatories to the ILAC
agreement. This means that there is mutual recognition between UKAS and
NIST NVLAP traceable calibrations. For further details of the mutual
recognition see http://ts.nist.gov/ts/htdocs/210/214/docs/mra.
htm
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FAQs
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