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


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

BioPharm International

The technology tools used to implement controlled electronic filing cabinets are often enterprise document management systems — such as the standard eContent Server from EMC Documentum, LiveLink ECM from Open Text Corporation, or ECM solutions from Hummingbird, Ltd. — or are point solutions offered by specialty contract research organizations such as ClinPhone Group Ltd. or Quintiles Transnational Corp. The solutions can range in complexity from configured, out-of-the-box software to systems with heavy customization that facilitate document bar coding, user-friendly document importing, scanning, and quality assurance measures. The normal precursor to a controlled filing cabinet EDM system is a set of shared drives on a network — a solution that is often difficult to scale and control.

In this controlled-filing-cabinet state, solutions are often implemented in conjunction with scanning environments — such as those offered by Captiva Software Corporation or Kofax Image Products, Inc. — and frequently augment a paper-based system of record. Even if paper remains the official record, the system is invaluable for its ability to enable users to: (1) create reconciliation reports based on document metadata; (2) retrieve documents without leaving a computer; (3) search for documents based on the text; (4) check status to ensure documents have been submitted or completed; and (5) allow multiple role-players to view the document at the same time. Maturity state 2 is normally a relatively rapid implementation with quick value — systems typically can be implemented in a validated manner within four months.

The controlled electronic filing cabinet is a solid step in moving up the maturity cycle. The ability to view content is usually assigned on the document level or content level, providing role-facilitating capability and alleviating the need to travel, photocopy, and carry large volumes of paper — in processes where multiple groups need access to a document at one time or where manual paper movement is absolutely required for record-verification purposes. Most importantly, it helps system users and administrators to start thinking in "document management" terms.

Maturity State 3: Compliant EDM Solutions

Compliant EDM solutions are systems that build on controlling access to final documents by controlling their creation, review, and approval. Further, they enable documents to be placed into retired or obsolete life cycle states. Hallmarks of compliant document management are well-defined document life cycles; unique groupings of mandatory attributes around document types; specification of role-players in the form of authors, reviewers, and approvers; controlled change requests; version and printing control; electronic signatures and promotion; and finally, full audit trails.

These solutions are most likely built on enterprise-class EDM solutions such as Documentum's eContent Server with Documentum Compliance Manager, or Open Text's Livelink for Regulated Documents. When considering controlled documents — either once controlled filing cabinets are implemented or, more importantly, when implementing a compliant document management solution — it is critical to begin considering new software tools to add functionality (e.g., hot back-ups, fail-over, and disaster recovery; EDM and enterprise portal integration; compliant document management package; or records management).

For hot back-up — back-up performed on a regular basis without bringing the system down — "cover-your-assets" products serve as a good example. Clustering services from VERITAS Software or BEA Systems are examples of disaster recovery and fail-over tools through their ability to cluster servers. Both Documentum and Open Text (Livelink) offer a host of gadgets to integrate document management "in-boxes" with enterprise portals.

When it comes to compliant document management packages, Documentum Compliance Manager (DCM 5) serves as a good example of a partially configured tool that can provide substantial functionality toward a compliant document management solution without the need to expend large sums of money. The integration of some important records management functionality into the Documentum 5.3 eContent Server provides a highly configurable and integrated content control platform that can be upgraded with minimal technical or validation effort.

Other solutions such as Adobe Systems' intelligent forms, Acrobat, and Reader should be considered here for obtaining e-signatures from external resources; providing cursory annotation services; and controlling access to original content.

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