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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 v:kit
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.
nlg's
qualification after repair service is an ideal answer to this
requirement.
the modular nature of our qualification tests enable just the
repaired module or functionality to be qualified. the flexibility
of the service means that qualifications can be ordered in the following
ways:
1. full breakdown cover plus qualification after repair
nlg service perform the repair and them immediately qualify the repair
2. qualification after repair
customer or other service providers performs the repair and nlg service
qualify the repair
each
laboratory will also 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...
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