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."

What’s Wrong with PowerPoint as a Document Authoring Tool?

In our McCulley/Cuppan consulting work we recently had a new client invite us to work with an authoring team on applying best practice to the planning, writing, and reviewing of a regulatory submission document. The document was going to be a significant piece of work, requiring over 500 pages and involving multiple authors across several scientific disciplines.

At the first meeting, the project leader announced she wants to continue the use of PowerPoint (PPT) as the document planning tool. Reasoning for this approach was in part because she and other team members already invested considerable time and effort in generating a 540+ slide deck representing data and messages to be in the regulatory document and PPT was a very familiar tool from extensive use in developing presentations.

I have to say we were mildly surprised by the demand to use PPT as the primary tool to plan and outline such a large, complex document. We have encountered other organizations using PPT for document planning purposes, but never on such a large scale. On the surface, the choice of PPT as the tool to produce initial draft documents seems reasonable. It is familiar to many, provides an authoring environment that produces output that can appear on screen as an outline, can be commented on in oral or remote review, and can be easily augmented and updated. All of these apparent benefits would support an argument for using PPT as an outlining tool to plan any and all documents. However, the use of this tool does not readily scale to developing large, complex technical documents.

Christine Haas, Karen Schriver, Thomas Huckin, Edward Tufte, and others tell us much about how readers interact with and read texts. From this collective body of work we have learned some things that can help us produce texts in an effective manner that, equally, is perceived as of very high quality. The prime method is to use tools that enable the design and review of texts as you expect your readers to engage in the reading and analysis of the text.

Successful collaborative authoring is significantly rooted in careful and thorough front-end planning. Choices of authoring tools are among the critical aspects of the document planning process, as tool choices impact (enabling or constraining) every other aspect of the planning and documentation processes. As authors and managers of authors, it is incumbent upon all of us to choose tools that accommodate our desired set of outcomes. Authors and managers must be cognizant of authoring tools that accommodate not only themselves and their ways of working, but others as well.

It is our position that use of PPT for document planning negatively impacts all potential collaborative authoring and review outcomes. Our claim assumes that the goal of the work is to generate an effective document, economically produced, that meets or exceeds end-user expectations.

I have outlined here key advantages and disadvantages of using PPT to plan and facilitate documentation of a multi-year, complex pharmaceutical development work.

PPT Advantages

• use is a habituated format; it’s familiar.

PPT Disadvantages

• presentations constrain data reporting rather than facilitate collaborative/interpretive processes (see my previous blog post on PowerPoint presentations).
• format creates/maintains a huge but fragmented vision of the process and product, impacting output (see Schriver and Tufte).
• PPT does not scale well to large documents as it limits information organization and searching is cumbersome, impacting review and the authors' ability to migrate material from PPT into a document-based format.
• PPT presentations do not accommodate major revisions/reorganization; impacting logic, content, and organization of the ultimate document product (see Schriver).
• the output decreases in clarity as the number of slides increases, impacting author/reviewer interpretation (see Tufte).
• PPT output is not a document; conversion to MS Word format is inefficient, time-consuming, and expensive.

The point seems clear in the choice of using PPT as an authoring tool is that familiarity wins, despite that, from a business, work, or quality perspective, the disadvantages of PPT clearly outweigh this single advantage. Eschewing proven document authoring platforms for the familiar may have unintended consequences and bear a high tariff.

Originally published on our Knowledge Management blog