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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, half don’t.
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 customer problems.
The moral 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 manner.
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 80 countries.
Why not have a look at our site right now;