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Extension - what is the key to do it in a compliant way?

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

Deviation management - how to capture our event the best way?

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

Deviations during requalification

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

OOC/OOA - how to handle it?

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

Retest - when you need the most, but how?

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....

Quick thought about RPN-calculation

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

World of CAPAs - part 1

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

Be brave! Kill your abandonded records!

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...