Submission Folder\File Structure for 100% Score on BEST\FAGG eCTD Checker

As some of you may know, the Belgian authority has released a Java-based utility to check for folder and file naming conventions in an eCTD (and conceivably NeeS) submissions.

Although most seem to be compliant with standard, eCTD conventions there were a couple places where I had to use trial and error to get that elusive 100% score. If you'd like to take a look at the names that I finally used to get the score pictured below, they are included in a ZIP archive that may be accessed by following this link. Note: Replace folders named *.pdf with an actual .pdf file in order to get the 100% score.

Explanation of Sharepoint\Documentum Integration

For years, Documentum has been the leader in the Document\Content Management space in Life Sciences, and especially at larger companies is available in some way or another. With the release of MOSS (Microsoft Office Sharepoint Servcies) 2007, Microsoft introduced some of the same concepts with a friendlier look and feel, lower implementation costs, and (perhaps most notably) a more elegant integration with the front end Office applications that end users access most.

The concern has been around how Sharepoint stacks up to 21 CFR 11, and other industry compliance concerns. Some vendors are working to bridge the gaps Sharepoint itself, while EMC has proposed an integration between Sharepoint and Documentum to essentially get the best of both worlds. In this video, Lance Shaw, Sr. Product Marketing Manager at EMC explains the approach and benefit of this integration.



In particular, I wonder if this could address the rendition problem, which has been cited by in Life Sciences as a gap in the Sharepoint product. This impacts regulatory in particular, who create much of their content in Word but must provide PDFs to regulatory authorities.

Welcome

Welcome to my blog on the latest happening in the regulatory realm of Life Science globally. Although the scope of this blog is more than just eCTD, that is clearly one of the main topics in the industry, and right now it will be difficult to totally remove our focus from that area completely.

With the transition to eCTD, more and more companies are reevaluating other relevant portions of their business, notably document management, document authoring, and drug labels which will be approved by the agency. Ideally this blog will provide an area to record and share thoughts about these trends, their implication and the technology that will shape the way life sciences organizations do business today and tomorrow.