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Why are documentation practices so inefficient?

Why are documentation practices so inefficient for many pharmaceutical and medical device companies?Many pharmaceutical and medical device companies feel that their current documentation processes are inefficient. Since a 2006 poll, when a whopping 75% of companies said that they feel that way, few things have changed. Then as now, most drug and device companies are planning to either investigate or implement a solution.

On one hand, it is easy to wonder at the lack of progress. On the other hand, the documentation practices at medical device and biopharma companies are unusually complex, in part because they involve so many different parts of the company (labeling, clinical, non-clinical, regulatory, and medical affairs).

The biggest pain points are related to:

  • formatting of documents,

  • re-creating documents from other documents and data sources that already existed within their organization, and

  • inefficient creation, review and approval processes.
One of the explanations may be that many drug and device companies still rely on formats like MS Word and QuarkXPress for their documentation. However, as the demand for information continues to grow, companies are experiencing a widening gap between their capabilities and requirements.

Even though XML can solve issues like redundant content creation and exhaustive time spent on formatting of documents, few companies embrace it. However, as more drug and device companies realize that XML can reduce translation costs by 60%, use of the technology is sure to become more widespread.

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1 Comment:

  1. Peter Fournier said...
    In my opinion, one of several key reasons is that documentation management is isolated in the overall hierarchy.

    Moving management responsibility directly under product line management opens the possibility of making the case of spending $1 here in order to save $10 in, say, product support/help line costs.

    A second important reason is the notion that managers can in fact know what's needed.

    The solution to that is to find a young manager and tell him/her that he can have a group that is funded through cost savings, year over year, in the documentation process. Then give him lots of rope and some support. The experiment will last a few months to at most a year. Starting costs can be minimal -- 3 person years is plenty. If the young manager can't find the cost savings he's out and you can try again with another one. He will inevitably migrate your documentation process to XML, but, but, but, pay attention now ... in a cost effective and MAINTAINABLE way.

    Moving to XML, just to be in on the latest fad, will not solve the inefficiency problem -- in many cases it increases the problem. For example, you need to put non-performance penalties in your XML CMS provider's contract specifying 100% validated linking. Given penalties that are even a a quarter as high as your costs if you lose all your linking, you will find it very hard to even find a provider that will sign the contract. Valid linking is only one of the problems that XML exacerbates.

    How do I know this -- because I've done it. Base documentation suite 150,000 pages. Three releases per year. No page more than 12 hours out of date. Total page count published per year - 4.5 to 5.5 million pages. All output in online help, PDF, and HTML simultaneously. Page counts quoted above are raw FrameMaker pages -- no double and triple counting for various outputs. If pages counted are for each output that makes over 15 million pages per year. Writer training time 4.5 hours.

    Maximum team size to do that: 5 + one manager. 2 of those people were assigned to producing an online help system that ran on telecom servers with 99.999% reliability.

    Why are documentation practices so inefficient? It's a culture problem. Never has been a technical problem. But you need to make documentation efficiency somebody's business. :)

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