Transfer of messages is not about what is sent, but about how it is received. Too often regulatory documentation contains gobbledygook (language that is meaningless or excessively technical). Too often, authors put their full train of thought in writing, assuming the recipient has the same background information for understanding what was meant.

Lean and concise messaging clarifies what is meant and what is not meant. Reuse of the same messages in different context also adds to the understanding. It was Mark Twain who wrote ‘I did not have time to write you a short letter, so I wrote you a long one’. This is exactly what happens too often in regulatory documentation, causing different and unintended interpretations. Moreover, redundant information becomes hard to manage in the future dossier lifecycle, resulting in inefficient use of resources and increased risks for inconsistencies within the dossier and/or across dossiers. These inconsistencies cause a regulatory compliance risk and does not build trust in reliability of the documentation as a whole.

Qdossier’s best practices define that factual information is to be presented in tabular formats facilitating lean authoring and structured content management. One will be surprised how much information can be presented in a table, which is more intuitive and unambiguous than a narrative text.