Daniel Hahn
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The "vision" to implement compliant electronic document management (EDM) systems — with process facilitating and monitoring
functionality such as template-based authoring, fully automated work flow, electronic signatures, submission-status portals,
and filing through fully digital backbones — has existed for decades.
Until recently, the combination of vague regulatory agency guidance and fragmented technology has prevented both large and
small pharmaceutical companies from fully achieving the vision. Yet many companies have invested millions of dollars and
years of manpower to implement marginally successful, compliant EDM solutions.
To successfully achieve the vision and effectively manage EDM projects, first categorize the current state of your EDM system,
then build a road map with manageable phases to reach the desired end state.
The goal of this article is to provide: (1) real-world examples of valuing EDM projects; (2) methods for categorizing a required
solution; and (3) useful guidelines and rules of thumb for building a road map after the solution has been categorized.
VALUING AN EDM SOLUTION
Building a road map is a natural starting point for any well-managed project. With EDM projects, visioning and road map activities
become especially important for several reasons:
- There are likely many EDM projects within the organization
- The purpose of various projects may be convergent or divergent
- Managing expectations of the various constituencies is extra-ordinarily difficult with the potential functional solutions
that EDM can provide
- Achieving any specific value, either business functionality or financial, is particularly difficult if a company attempts
to do everything simultaneously
- Compliance and coordination issues associated with multiple projects and poor project mapping can cause a budget to balloon
by more than 100 percent.
Categorizing EDM Projects
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By way of narrative example, the clinical operations function at most life sciences companies produces documentation to effectively
manage ongoing trials, monitoring documentation such as visitation reports, protocols, and amendments; investigator's curriculum
vitae and licenses and general correspondence. Additionally, medical writing groups typically develop clinical study reports
and other final documents that appear in US Food and Drug Administration (FDA) submissions.
Electronic trial master file (eTMF) systems differ substantially from submissions management systems in that eTMF systems
control, organize, and share study-related information within the clinical operations group. A submissions management system,
on the other hand, controls inter-functional processes — among groups such as regulatory affairs, quality assurance, and clinical
operations — of published content in individual leaf documents (such as FDA's 1572 clinical investigator form; or FDA's chemistry,
manufacturing, and control [CMC] document) related to an investigational new drug (IND) or new drug application (NDA).
