More on What is a Document?

So what is a document?

In response to my last blog post, I have been asked by several individuals—"so then what is a document?"

My short answer—"I do not know for sure."

Now for the long answer.

The widely accepted definition for a document is as a textual record. This definition served us well in the past. But now with digital records, semiotics, and information retrieval tools; I am not sure the definition meets the needs of how we communicate in 2012.

As early as the 1930s Paul Otlet, an Information Scientist of considerable renown, suggested that the definition of documents also include digital images and even three dimensional objects. I am not prepared to toss all the elements Otlet describes into the mix. But I am prepared to suggest that documents are organized physical evidence and as such the organization transcends the classic definition for a document as this vehicle is a less relevant communication medium in 2012 than it was is 1982. I do not have a preferred term, I wish I did, but I do suggest we attempt to move away from the term document as it suggests a domain for organized physical evidence that does not match the reality of the digital age.

Suzanne Briet suggested a definition some time ago that a document is evidence in support of a fact. I rather like this notion. She makes the point that documents should not be viewed as being concerned with texts, but with access to the evidence. I suggest this is the essence of all regulatory writing that I talk about often in this Blog. If one considers the models in place for electronic drug submissions, thinking in the classic terms of 8.5 x 11 and A4 is really not very useful.

Rather it is better to be thinking in terms of taxonomies of information or perhaps even semiotics. Semiotics is the study of signs, indication, designation, signification, and communication. Semiotics is closely related to the field of linguistics. I look at semiotics as a valid attribute for this discussion because the life sciences are driven by numbers and what are numbers, but signs and the significance of those signs.

Then there is Michael Buckland who talks about how a key characteristic of “information-as-knowledge” is that it is intangible: one cannot touch it or measure it in any direct way. Knowledge, belief, and opinion are personal, subjective, and conceptual. Therefore, to communicate them, they have to be expressed, described, or represented in some physical way, as a signal or communication.

What we are really talking about happening in regulatory submission packages is the conveyance of knowledge.  This conveyance often transcends the boundaries of a traditional text, that is, a document as it is generally defined. The Briet notion of "evidence in support of a fact" works well as a definition of a document especially if we change the quote to read "evidence is support of a claim."