Managing Documents and Records, The Never-ending Process

By Stephen S. Dallas

That was the theme of the 21st annual DIA Conference for Electronic Document Management (EDM) hosted in Philadelphia on February 5 through 8. The goal of this year’s conference was to focus on grass roots; getting back to basics and best practices. While the intent was not specifically about the transformation to an electronic ‘state’ and the associated evolving standards, it was evident many attendees still want to know how to get there. The overarching theme for the conference was the “Never-ending Process”.

If your profession involves the management of electronic information in the Life Sciences industry, then the annual DIA Conference for Electronic Document Management conference is for you. This year’s conference afforded attendees vast opportunities for knowledge exchange and more importantly the ability to provide input and feedback to industry leaders and government regulators.

DIA President Ron Fitzmartin stressed the importance of this particular conference reminding the audience of the overall DIA mission, which states, “…sharing information that optimizes the process of drug development and lifecycle management.” The statement itself does not include the words ‘document’ or ‘electronic’ in it however it does infer best practices, collaboration, and the overall process. This is truly grass roots and indeed never-ending. In my opinion, the conference succeeded in meeting its stated goals, while keeping within the spirit of the DIA’s mission.

There was a broad spectrum of speakers from industry, technology and service providers, and FDA. The provider area included the anticipated mix of firms partnering, competing, and sometimes both to promote their business values.

There were four main themes permeating this year’s EDM Conference, including
Best Practices, Standards, Regulatory Trends and Metadata.

Everybody wants Best Practices and the conference was full of them, however many resulting from years of experience and hard work by individuals or small groups. More can be done to compile Best Practices across the industry to include a broader base and objective evidence. This would facilitate wider acceptance and expedite implementation across organizations.

A lot has been done. If you are of the opinion that standards and best practices are related, initiatives like the Electronic Common Technical Document (eCTD) have proven effective. One speaker made an interesting point that good standards allow authors more time to spend on content.

Standards were also discussed extensively, especially as they relate to Health IT initiatives, both during opening day on Wednesday and on ‘FDA Day’ Thursday. In fact, a lot more was mentioned about Health Care related issues than I expected to hear at a DIA conference, with Interoperability of Health IT systems mentioned as an area of growing concern. The question was raised, “If we advance technology for interoperability, Who should pay? Who would benefit? What would be the business case?”

FDA representatives were surprisingly vocal at the conference. The agency acknowledged that there are fewer employees with an increasing amount of work to do with an IT infrastructure in need of an update. Michael Fauntleroy, Dir. Electronic Submissions, CDER, jumped off the stage and into the audience to talk about the Gateway, Validation Checks, Waiver Policy, and other topics regarding how to submit an electronic dossier to FDA. This was practical and valuable information. His delivery was a real treat, effective, and kept us wide awake.

FDA representatives talked about the agencies drive to provide industry with guidance as a means to drug safety, as opposed to instilling fear with the actual power they possess. This point was illustrated by two images; “Mr. Rogers” versus “The Terminator”. A bit extreme but gets the point across. That’s getting back to basics, human communication basics.

We were reminded that when FDA reviews an application, in fact there are two human beings communicating. So when you assemble your dossier, put yourself in the shoes of the person who will have to review it. This idea was cited in several discussions regarding hyper-links and bookmarks in an eCTD. Someone asked how much is enough. The answer was, “If you had to review it, what would make your job easier?” By the way, the larger the document, the more useful the links can be.

While there are obvious benefits to EDM in reducing the product development lifecycles and thereby getting drugs to market faster, the FDA is still dealing with the challenge of doing more with less people and less paper.  Although electronic submissions do not guarantee shorter review cycles, shifting to eCTDs is of special importance, since we learned at the conference that CDER’s paper repositories are full. 

Naturally there was a significant focus on eCTD. I attended the Electronic Odyssey tutorial on Tuesday. During the session, the point was driven home regarding the interdependence of EDM Systems (EDMS) and eCTD. A successful EDMS implementation must be created with the end in mind. A key “Lesson Learned” was that large organizations should not aim to have a single, monolithic EDMS/eCTD system. This overarching strategy, although interesting from a consolidation standpoint, doesn’t seem to work in practice. Instead, companies should look at federated systems linked with ‘connectors’. When you take into consideration the current trend toward outsourcing and information coming from 3rd party partners, federation is even more appealing.  Regardless of the implementation strategy, EDMS output should be displayed with the understanding of how a reviewer will need to consume it.

I had the opportunity to discuss the topic of eCTD, with a “Big-Pharma” executive. We discussed what worries him most about eCTD. He amply replied, “It’s not the format of the eCTD, but rather getting the content compiled, complete, and accurate.” There are no new content requirements of eCTD over CTD.

Metadata also took the spotlight with an entire tutorial dedicated to the topic. Implementing a successful EDM used to prepare eCTDs requires careful metadata management. If you don’t, it can be hard or impossible to change metadata downstream. Pfizer presented a nice system for RA document archiving. It was created by first collecting metadata using carefully thought out methods and then leveraging that metadata to build the system. The result has no folder structure! This is the essence of metadata. It is a commendable task for such a large company because the more users, the harder that ‘shift’ can be. A lengthy discussion ensued about folders and how hard it is to get away from them.  Microsoft said even though Windows will be folder-based for the foreseeable future, one can eliminate them in a well designed EDMS. Finally, one attendee pointed out that a well thought-out folder structure can actually be directly used to create a metadata-only design.

The transformation to fully electronic data management is still uncertain, complex, and indeed ongoing. With such a complex field come silos of knowledge. Nobody knows everything, so the ‘sharing’ part of the conference was highly valuable. This is the 21st conference of its kind. One might think after decades, we might have it all nailed down, etched in granite. Yet this is not nearly the case. There is still a lot of uncertainty, many failed attempts to build a good working systems upon, and of course ever-evolving technologies and regulations.

The theme of getting back to grass roots was a good one for this year, and to that end I would like to propose a new acronym, LSIM, for Life Science Information Management. Who needs the ‘E’, it’s implied by now. We talk of Records, Content, Documents, Data, and this year a lot about Metadata; all of it is Information. Whether you interact with this information through an LCD or paper, generate it in the lab or from a study, create it or consume it, you must always remember that you are communicating information from one human to another.

Stephen S. Dallas is an independent consultant providing EDM Project Management services to Life-Science companies. Over the last ten years, he has managed the implementation and validation of Enterprise Content Management systems across a wide variety of pharmaceutical companies, ranging from startups to those in the Fortune 100.

Stephen can be reached at (484) 995-6396.

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