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Have you downloaded our free Vendor Audit Check Sheet, or
our free Validation Glossary? If not why not do so now:
CAPA remains the
single most cited subject in the medical device industry, with 50% of FDA
warning letters being concerned with CAPA problems.
Why does this not surpriz me? Because having worked in the industry for many years, I have mixed with companies who paid
scant regard to the subject. Yes,
there are companies around who do the job properly, but according to statistics,
I think most persons
who have worked in the industry for any length of time, have seen the occasion
when production output has taken priority over the proper investigation of
to the story, cost, is it more cost effective to have a compliant CAPA system that
is not only keeping you compliant with regulatory requirements, but also
producing data that enables you to reduce customer complaints and quality
deviations; or is it more cost effective to pay lip service to CAPA requirements
on the bases that you don’t have many customer complaints.
Validation Online has
just released a CAPA AUDIT document, which should be used to verify that your
CAPA system, whether manual or electronic is being used in a compliant
Our most popular
purchase still remains the Validation Package 3. This contains all the protocols and
associated procedure documents required to carryout a validation task.
Our most common
technical enquiry is still the question asking; Does a validated piece of
equipment, that is moved from one area to another, require to be revalidated,
even if the move is only across a room?
On our site are solutions to problems that
cost companies literally millions of dollars to remedy, read some of these
solutions free of charge. Need advice! we give advice on a daily bases, free of
charge to companies from every continent. Our documents are in use in over
Why not have a look at our site right now;