I'm sure you need to work with deadlines. 30 days' lead-time for deviation or complaint investigation, also hard deadlines for CAPAs and...

Several different guidelines, laws are mentioning requirements about deviation management, but mostly about the essence of...

There was a post earlier about how to manage OOC investigations. But what if your service provider has its own deviation management...

In case of analytical instruments, some companies use the term Out-Of-Calibration, others use Out-Of-Acceptance for failed recalibration...

Okay, here's a situation: you did your QC-test*, and the result is OOS out of the blue- but you know, you really know it is a lab error....

One of the easiest and quickest risk assessment tools is the classification of deviations through Risk Priority Number (RPN) calculation....

CAPA is basic process in all pharma companies, being not only a mandatory one, but can (should, must) be also an asset in continuous...

Even the best companies might face the situation that an old unclosed event fall out of the closet. It can be a two-year old CAPA, a...