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

Since documentation is one of the cornerstones of Pharmaceutical Quality Systems, EU GMP Volume 4 dedicates a full chapter (Chapter 4) in...

Organization change is always fashionable. 'Let's start to centralize', 'Let's start to decentralize', 'Let's dedicate a team'. There may...

In part 1, I cautiously questioned that the big-guy change control system should be used for every change. Let me give an example area:...

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...

Every pharma company has a well-established Change control system with the related system, SOP etc. But is that the best platform to...