Optimal Documentation Structure

The pharmaceutical industry is constantly challenged to comply with new regulatory requirements.

Well established companies have grown their document portfolio from a very simple structure of few specifications to now more than 100 different document types.

The industry is now facing databases of high complexity with low visibility controlling their documents.

The problem for most companies is, that they never had the time to streamline the document structure.

Hence, a variation of a product is likely to generate lots of new documents instead of updating exiting specifications, harmonizing and utilizing platforms.

It is not only an internal company issue as it generates extra communication with external stakeholder such as suppliers, CMO, partners and authorities as well.