The pharmaceutical industry is living in an instant challenge to keep compliance with new regulatory requirements.
Well established companies have grown their documents from very simple structure of few specifications to now over 100 different document types.
The industry is now facing databases of high complexity with low visibility of control their documents.
The problem most companies find themselves in; is that they never had the time to streamline the document structure; like variation of a product could most like generate lots of new documents rather than just update exiting specifications, harmonizing and utilizing platforms.
It is not only an internal company issue. It also generates extra communication with external stakeholder as supplier, CMO, partners and authorities.