The Evolution of Electronic Document Management Systems in Life Sciences – Part 2

The evolution document management has lead to an enterprise-wide strategy which encompasses the entire content life cycle from creation and approval through to retention and disposition.

Employing an enterprise strategy is something that many organizations desire, but few have achieved. As the concept evolves over the next 3-5 years, organizations will need to consider the following:

· How can they unify and integrate the organization’s critical business content so that they can support multiple geographies and functions? Organizations will want to include information from both structured and unstructured information systems in a seamless way so that the content can be searched, retrieved, and shared.

· What can be done to eliminate information silos? Rapid evolution of technology and a response to increasing regulatory requirements has resulted in environments that contain point solutions and information silos. Some processes can be transitioned into an ECM environment, and supported through robust workflows and detailed reporting; other processes will need to be supported through integrated point solutions.

· Will the content management platform grow with the organization? There are a number of points to consider when it comes to the growth of an ECM system. Organizations need a system that can scale from a technical perspective to support more users and more applications over time, and should consider satellite offices and low-bandwidth connectivity in this analysis. Also, flexibility -- if applications can be readily configured and deployed, the organization can do more with the content management platform in a shorter time. Organizations should look for a system that can meet their needs through configuration, rather than customization.

· How much will it cost? Organizations need to do a full analysis up-front taking into account their enterprise strategy for content over the next several years and ensure they understand the scope of everything that needs to be accomplished with their enterprise content management system. It is not just about buying the software. Organizations who make investments in the implementation, training and the configuration of applications in the beginning, end-up spending less over the long run. The ideal system should provide the organization with the ability to create and modify applications without significant training and implementation costs.

Pharmaceutical companies are taking steps to ensure they’re on the right path to an enterprise architecture by leveraging existing technology solutions and content repositories, and coupling them with a next-generation enterprise content management framework. Powerful enterprise search functions, security controls to ensure appropriate access, metadata capture, secure information retrieval with process automation tools, and intuitive retrieval capabilities are all required to ensure content is available to appropriate users when they need it and in the context of how they are working with that content.

The emerging industry need for an enterprise content management strategy in life sciences will force Pharmaceutical organizations to more effectively leverage content and metadata investments across applications and the organization, and provide a unified view of structured and unstructured business content for significant productivity gains and better decision-making.

The Evolution of Electronic Document Management Systems in Life Sciences – Part 1

Traditionally, electronic document management systems focused on the needs of Regulatory Affairs and provided several basic functions such as document security, version control, document control and electronic approval. EDM systems have grown over the years to accommodate the needs of chemistry, biology, pre-clinical, clinical, quality assurance, quality control, medical writing, legal and compliance. Enterprise-class systems that scale and accommodate a range of business processes have flourished with these increasing demands on the EDMS.

In the past, organizations focused heavily on the document management aspect of content management, and neglected issues such as retention, archival, workflow and reporting. The evolution document management has lead to an enterprise-wide strategy which encompasses the entire content life cycle from creation and approval through to retention and disposition.

Through the benefits of information sharing and reduced duplication of efforts, pharmaceutical and biotechnology companies are recognizing the pure cost advantage of a single ECM system for the housing of all business content. By deploying a single ECM platform for the management of finance and operational content, drug development documents, clinical trials and patient record information, standard operating procedures (SOP), and quality control documents, companies can lower the total-cost-of-ownership of content management technology. With integrated business performance enhancement capabilities such as business process workflow, group collaboration, and intelligence reporting, organizations can implement automation to their processes, on top of their document or content management platform.

A content management system may support the following industry-specific applications: regulated content approval and control, submissions content management and assembly, quality issues tracking and corrective and preventative actions management, and learning management. And the following enterprise applications: records management, business process management and workflow, contract and vendor management, business intelligence and reporting, ERP data and document archiving and integration, and email management.

A true enterprise approach touches on a wide range of technologies and business processes.

Welcome to my Content Management in Life Sciences Blog

Organizations in the life sciences industry deal with millions of documents, and hundreds of millions of pages of information; Enterprise Content Management gives these organizations the ability to gather, process, and manage these documents more effectively.

In this blog, I will be discussing the evolution of ECM in Life Sciences. I will look at trends in the industry and what I see going on with respect to content management technology. There are many changes with respect to ECM driven by industry challenges such as a decreasing product pipeline, and increasing competition and globalization; regulatory pressures related to industry harmonization and increased scrutiny; as well as emerging IT infrastructure challenges.

As you can read in my biography I have been focused on enterprise solutions for many years, I have spent most of that time focused on vertical and horizontal applications. I would like to hear from you in response to any of the topics posted.