All persons within the organisation should be involved in and support the pharmacovigilance system on the basis of task ownership and responsibility to a degree according to their tasks and assigned responsibilities.
Implementing READY! helps all departments communicate and easily track and find correct product information and associated documents.
The QPPV is responsible for the complete pharmacovigilance of the MAH’s medicinal products and promotes, maintains, and improves compliance with the legal requirements. To accomplish these duties, the QPPV has to be up-to-date with the status of the MAH’s products.
A quality system has become an integral part of Pharmacovigilance. It is essential to assure the connection between both internal and external stakeholders.
READY! is used extensively by the QPPV and Pharmacovigilance teams to:
In addition to finding available information about medicinal products, they can use READY! to make their life easier by:
Validation is a standard part of the implementation of READY!.
READY! is based around the idea that companies need updated, current information about their products in all of their iterations.
READY! has been developed to meet specific needs of management of structured (IDMP medicinal product information) and unstructured information (documents, forms, records) in pharma industry.