PI must be updated as soon as changes to the SmPC and PL are authorised by regulatory authorities.
READY! tracks changes across all relevant PI annexes and products, and it eliminates many manually performed tasks and redundancies that are potential sources of error.
Using the READY! automated process simultaneously changes, or flags for change, all locations where the information occurs, leading to faster updates and reducing the risk of introducing errors.
PI contains the same information linked to several products and strengths registered in several countries, each of which has to be changed individually in case of an update to the information.