Spotlight on 4th Generation Electronic Document Management (EDM) Systems - Advances in technology and methodology may bring compliant EDM systems to the masses. - BioPharm International

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Spotlight on 4th Generation Electronic Document Management (EDM) Systems
Advances in technology and methodology may bring compliant EDM systems to the masses.


BioPharm International


Not all systems need to be fully automated publishing systems; controlled filing cabinet functionality may be the desired endpoint for an application. As with any system, the endpoint should be commensurate with the value that a system — and its users — can achieve. Second, and only marginally less important, is that maturity states 2, 3, and 4 build on one another — each is a logical, stepwise progression through the implementation process.

EDM Project Planning Guidelines

Many business project sponsors argue for skipping the controlled electronic filing cabinet state to achieve artificial deadlines or because the real value is perceived to come from controlled document management. However, it is this controlled electronic filing cabinet that usually focuses the users on folder structures that suit their business needs. This focus on business needs and structure normally leads to the comfortable identification of document types and subtypes. Once the document types and subtypes have been selected, the list of metadata associated with each document type can be more easily generated. However, generating the list of metadata for each document type frequently proves to be one of the most arduous activities in specifying a system — an activity that can derail a project if a project is over-scoped.

Build your road map so that each state in the maturity cycle is independently achieved. These maturity states can become high-level milestones on the planning horizon.

Project Planning Guideline 1 Apply proven rules of thumb to estimate the project effort. Perform a check with the business sponsor to ensure that effort does not exceed business value.

For a non-validated implementation of out-of-the-box EDM tools, such as Documentum eContent Server, requirements should consume about 33 percent of the overall project time, design and configuration should consume 33 percent, and testing and training should consume 33 percent. For a validated solution, applying a moderately rigorous validation procedure, the total hours allocated for requirements through training could be multiplied by 125 percent and 133 percent; the cost of validation (or "validation uplift") often proves to be at least 25 to 33 percent of the total implementation cost of the solution.

Based on maturity state and organizational knowledge, estimate the requirements gathering effort, then apply a 1/3-1/3-1/3 rule of thumb to estimate the overall effort. Finally, work hard to define your organization's validation uplift, and apply this uplift to the effort estimated with the above rule of thumb. The estimates can be refined as the project moves forward, but these initial estimates are a great reality check to determine if the business value articulated in the charter exceeds the effort required.

Project Planning Guideline 2 Plan in 16-week time periods. Schedule logical project plan updates (called "stage gates") within the 16 weeks to ensure that estimates are revised and that the project sponsor has full visibility for the effort and budget.

For a single group implementing a compliant document management solution using a package such as DCM, validated implementations with a full out-of-the-box life cycle and having a limited number of document types can be performed in four months by implementation teams as small as four people.

As with any estimate or forecast, accuracy increases as more information is known and as one moves closer to the time period in question. Choosing manageable planning horizons will aid in connecting a company's current state with the desired end state. It is advisable to use 16-week time periods to manage implementations. A 16-week time frame is sufficient to implement a controlled filing cabinet and, usually, a modest compliant document management solution for one business function.

Within the 16 weeks, and especially if a full implementation will be completed within that timeframe, schedule stage gates between requirements, design and configuration, and testing and training. The stage gates can be used for reevaluation of and adjustments to the project plan. Once the adjustments are made, an interim "go/no-go" decision can be made.

Project Planning Guideline 3 Use a waterfall systems development life cycle to align the development life cycle with the project governance needs required for a validated EDM system.


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