Equally important as the chosen tool is the time required to define the life cycles, functional groups, role-players, document
types, metadata, and more. This need to effectively manage the investment often results in time-boxed projects and, therefore,
functionally "siloed" solutions. Because the EDM tool becomes process facilitating, and likely the system of record, there
are enormous standard operating procedure (SOP) implications and validation issues.
It is these SOP and validation issues that require substantial consideration in laying out the EDM road map.
Compliant document management is used most frequently by quality assurance groups for controlling SOPs or by regulatory affairs
groups to ensure the control of documents for regulatory submissions.
Process efficiencies are moderate for compliant document management, but high levels of document-handling and content-creation
compliance can be achieved. The cost of noncompliance, measured by lost revenue from stalled operations and labor required
to resolve FDA citations, is the primary driver of compliant document management.
Electronic signatures and process automating electronic work flows reduce circulation and document approval efforts. In conjunction
with a process-harmonization effort, these systems include templates with common nomenclature and structural standards specific
to each document type. It is the structure and automation that lead to high-quality audit trails, complete document histories,
and compliance-related reporting capabilities.
Maturity State 4: Highly Automated Publishing Solutions
"Templatization" and their electronic management lead to an acceptable level of preparedness for highly automated publishing
solutions. Highly automated publishing solutions require that documents have appropriate metadata — to accurately and electronically
locate the documents — and that they contain the appropriate tagging to locate content within the document. This ability to
locate a document, and "chunks" of content within a document, enables the division and distribution of content for multiple
uses and in multiple locations. It is the first step of transitioning to an XML backbone for publishing.
Highly automated publishing solutions integrate compliant document management to enable automated publishing of documents
and their more granular chunks of content. The automated publishing may be performed in electronic form — such as via templated
web publishing or an XML backbone. Alternatively, the publishing may be done on paper or in a file, such as an Adobe PDF,
that represents paper.
Submission software is the cornerstone for most publishing systems because submissions publishing is the bulk of the publishing
performed by pharmaceutical companies. The most prevalent companies providing publishing solutions are Image Solutions, Inc.
and Liquent, Inc. Their tools serve to map compliant leaf documents into submissions using the structures specified by various
government regulatory agencies.
Substantial effort goes into generating persistent bookmarks, hyperlinks, and tables of contents for any submission, even
with a submissions tool. The output of these tools is a submission in the form of printed paper, electronic files on a CD-ROM
or DVD, or document content placed in an XML backbone, representing a submission. Eventually, documents and content will be
placed in an XML backbone where updates are automatically transmitted to regulatory agencies in a controlled manner. It is
up to the publishing system to capture a snapshot of the virtual documents submitted.
Very few companies, if any, have achieved fully automated publishing and submissions. However, this is a vision, or endpoint,
that will be attained in the near future. The challenge is the implementation steps.
BUILDING THE IMPLEMENTATION ROAD MAP
Building the implementation road map for an EDM project requires both a top-down and bottom-up planning approach. The top-down
approach provides implementation teams with a charter. This charter normally includes critical sponsor-related planning elements
such as the desired end state, prioritized business requirements, and the business justification. The top-down elements cascade
to the bottom-up planning by helping the implementation teams understand how many maturity states they must work through,
the combinations of functionality that will maximize value through each maturity state, and the tools that will best scale
to the desired end state.
The remainder of this article focuses on guidelines for transitioning from the conceptual top-down EDM project chartering
to the tactical bottom-up project planning. First, five guidelines are provided for project planning. Subsequently, four validation
guidelines and one change control guideline are presented.