It’s 10 pm. Do You Know Where Your Documents Are?

As content management professionals in a regulated industry, we often focus on what it takes to get documents drafted, reviewed, updated, and, ultimately, approved. We gather metrics, tweak our methods, and redefine our processes all in an effort to increase throughput, enhance quality, and reduce document costs. And this is important – very important – because each year the amount of digital content being created increases significantly, a trend that drives additional cost and complexity into content management processes. Just look at life sciences promotional content. In the last 10 years, the number of promotional pieces that the US Division of Drug Marketing, Advertising and Communications (DDMAC) reviews on an annual basis has more than doubled from about 38,000 pieces in 2000 to more than 79,000 pieces in 2010.

But what happens to content once it has been approved? How is it used? Where can you find it? And how do you bring that content back or retire it? Too often the answer is “I don’t know” or “We could find out, but it would take days, weeks or even months.” Knowing where your content is and how it’s being used is especially important for life sciences content, and the benefits of doing this right can be tremendous: searches that take minutes, not days or weeks; greater control over market messaging; and the ability to update content quickly and accurately.

Below are three tips for better regulated document tracking practices:

• Begin with the end in mind – Make sure you know how your content will ultimately be used. For example, if there is content in a manufacturing technical report that will be used in a CMC regulatory report and, ultimately, in multiple global submissions, know that from the outset. Understanding how content will be used will help you avoid rework, duplicate copies, and other common content pitfalls.

• Know Thy Document Distribution – I’ve worked with companies that have devoted substantial time and resources to manually track down content once it has been distributed. Organizations need to find distributed content for multiple reasons. For example, you may need to find a promotional piece because the health authority has asked you to remove it from circulation. On the R&D side of the house, you may need to find where a particular document has been submitted so that when it is updated, regulatory can easily understand the impact on submissions to health authorities across the globe. Tracking the distribution of content once it is approved can save countless hours of trial and error search and recall, as well as reduce the cost associated with maintaining document content.

• Find a System with a View – An end to end view, that is. Too often, our view of the content life cycle is segmented. We go to one system to view the planning information, another to understand the development of the content, and a third (or more) to understand how the content is being used. This model of managing content can lead to duplicate content, version mismatches, and other content management nightmares. To avoid these, make sure your systems have the ability to view content status and use from concept or planning to development all the way to delivery and retirement.

Join the conversation! What are some tips and tricks you’ve used to enhance your document tracking practices? Please share them in the comments below.