Knowledge Management and Communication in the Life Sciences

I mentioned in this post that I consider the documentation practices for creation of regulatory submission documents in most pharma and medical device enterprises to rather unsophisticated. My position is largely driven by comparing observations of documentation practices to descriptions of varying levels of documentation maturity we have developed. Our descriptors have their roots in the work presented by Joann Hackos in her book: Managing Your Documentation Projects.

Like Hackos, our documentation practices-maturity model is a six point scale ranging from: Level 0 — Oblivious to Level 5 — Optimizing. My observations suggest that the vast majority of regulatory writing falls into the 2.5 range, which is between Rudimentary and Organized/Repeatable.

The Rudimentary documentation organization is one where the vast majority of effort is placed to ensure documentation consistency. All documents are generated utilizing well characterized templates. Document strategic review is largely absent as energy is applied to ensuring structural (that is, grammar and format) accuracy and consistency. Work practices are highly individualized and there is little application of meaningful estimating of document size or time lines.

The belief statements of organizations working at the rudimentary level include the following:

• All writers manage their own projects
• We would like to know more about our reading audience, but nobody takes the time to learn more….so we “suppose” what they want in our documents
• Our users are just like us…….I am a subject matter expert, so every other person educated like me will read documents just like I do
• We talk about what the data means, but we rarely talk about how to represent this meaning in our documents until we are into round table reviews
• We have little concern with how many rounds of review go into creating the final version of a document….we strongly endorse the credo “the end justifies the means”
• Planning document content before actually writing a report is just busy work
• We routinely reverse engineer document development timelines from the stated publication deadline and not from the scale and scope of the intended document
• We care what the customer thinks of our documents, but we do not use any organizationally applied quality standards. Standards are principally driven by teams and their senior reviewers
• File and forget–we do not take time to collectively reflect on documentation work practices practices

The belief statements of organizations working at the organized and repeatable level include the following:

• We have begun to study our document users but see little value in a concerted effort to collect information on how well our documents “satisfice” their needs
• We are surprised or even indignant when we get questions from our regulatory user looking for information that we included in our submission package
• The quality of our document project management is inconsistent, but we are okay with that because that is reality and each project is unique
• We do not see meaningful metrics beyond time for documentation projections…if we meet the deadline, then ways of working had to be good
• Nobody knows what others are doing in the process of review…the only way they know is via what may be discussed during a round table review
• We believe in our described “ways of working” until faced with unexpected situations, then we panic and call for “all hands on deck”
• We can easily get caught up in “process” at the expense of “product”

Now let’s contrast the above with belief statements of organizations working at the optimized level which include the following:

• We always engage in collaborative pre-writing planning of documents to make sure we fulfill strategic purpose of any given document
• We are thoroughly committed to understanding our document users and we work to systematically collect information from them
• We know how big a document will be even before we write it
• We always do end-of-project analysis to collect lessons learned and then disseminate this information across the organization
• We maintain a database of critical documentation work practice parameters and benchmark all documentation projects
• We recognize that accuracy and consistency are just the start of ensuring quality….we have expanded focus to quality of argument and document usability
• We are learning how to be innovative and not let the process control us