Document templates establish the look and feel of your dossier, but more importantly they promote compliance with regulations concerning granularity, formatting requirements and others. Templates provide direction for the authoring community so they don’t have to consult standards or become MS Word experts before doing the work they need to do.
Even if you’re not yet ready to produce eCTDs, creating eCTD-ready documents now will provide a major benefit and cost savings down the road. Every Life Sciences organization should.
Here are a few best practices around the use of document templates:
- Decide: Build or Buy – If you don’t already have templates mapping to CTD/eCTD granularity and abiding by formatting requirements, consider buying a set of templates rather than creating your own. There are several packages available at different price points and levels of sophistication.
- Control and Manage Templates – After you’ve obtained or created templates, make certain that they’re available to authors in a standard location, preferably your EDMS. Control all changes to templates by enforcing a review and approval process.
- Train Authors – Authors need to be trained in how to use templates and recognize why they are important. Once they understand the need for submissions to follow guidelines, they’ll be less likely to modify their documents in a noncompliant manner. This will avoid costly, time-consuming re-work by regulatory operations or outsourced publishing partners.
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