|
what
happens after an analytical instrument has been repaired - can it simply
go back into use or does the repair need to be qualified?
as
shown in an FDA 483 citation referenced in the compliance watch
section of our january
2006 newsletter, many regulated laboratories are coming to realise
that providing documented evidence that a repair has not impacted the
operational performance of their analytical instruments in now a must.
v:kit
is an ideal answer to this requirement.
the modular nature of the v:kit tests enable just the repaired
module or functionality to be qualified and the flexibility of the
product means that the qualification can be delivered either by the
equipment users or their designated service providers.
each
laboratory will need an SOP that describes their approach to
qualification after repair - nlg analytical can help to define the
contents of this document with recommendations of which tests should be
used to qualify specified repairs.
request further
details...
|