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.