Leading Analyst Firm Projects Major Shift from Traditional Document Management to Enterprise Content Compliance Solutions in Life Sciences Industry

April 20, 2010

New Study Highlights Vast Inefficiencies with Regulatory Information Management; Estimates a Quarter of Product Cost Attributed to Document and Compliance Issues

Cambridge, MA – April 20, 2010 Virtify, Inc., today announced the availability of a new IDC Health Insights study titled “Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance.” The new IDC Health Insights study, which was commissioned by Virtify, shows a growing trend in the life sciences industry away from traditional document management systems to emerging Enterprise Content Compliance (ECC) solutions. ECC solutions are changing and accelerating regulatory document preparation by enabling Parallel Authoring™ while automating the expanding regulatory compliance requirements surrounding submissions, labeling, and clinical trial disclosure.

The IDC Health Insights research states that the cost of bringing new drugs to market ranges from $800 million to $1.2 billion, and estimates that roughly a quarter of the cost comes from the content requirements associated with working in a regulatory compliant environment. The IDC Health Insights research also suggests that ECC solutions can substantially reduce the time and cost of bringing new drugs to market through improved abilities to manage collaborative teams, and compress the time spent authoring, reviewing, and submitting regulatory documents.

Over and above traditional document or content management systems, ECC solutions deliver advanced capabilities for Parallel Authoring which greatly improves the integration of key people and processes.  In doing so, ECC solutions reduce costs, time, and regulatory risk far above traditional manual or document –driven processes.

The new IDC Health Insights study is available on the Virtify website here www.virtify.com/idcreport and outlines:

  • The latest technology and content management trends based on comprehensive survey research and interviews with dozens of life sciences professionals
  • The evolution of “Enterprise Content Compliance” solutions and why they are quickly becoming a “transformative approach” to information management
  • How today’s structured content solutions are moving beyond traditional “collaboration” to next generation Parallel Authoring to compress timelines, reduce costs, and better integrate people and processes
  • How ECC solutions deliver rapid ROI and promote user adoption through intuitive word-processor interfaces and out-of-the-box compliance with new and evolving global standards
  • The cost advantages of a content-centric versus document-centric approach to regulatory submissions and compliance
  • Why the ability to identify and reuse key data elements is a critical requirement in creating additional and accurate regulatory documents (SOP, quality, validation, manufacturing)

“By combining capabilities for centralized content collaboration and reuse within a standards-based environment, ECC solutions, with a focus on content reuse is core to eliminating a significant amount of repetitious, low value, document-centric labor, therefore freeing up staff for more important efforts,” noted Dr. Alan Louie, research director for IDC’s Health Insights.

“This study clearly shows that life sciences companies are shifting away from traditional paper-based processes and legacy document management systems towards solutions that promote content reuse, resource efficiencies, and cost reductions,” said Satish Tadikonda, President and CEO of Virtify. “With ECC solutions such as Virtify’s, life sciences companies can leverage a unified platform to effectively manage regulatory content, compliance, and the many critical processes that are required across the complete product continuum.”

The IDC Health Insights study is available on the Virtify website at www.virtify.com/idcreport

Source:  IDC Health Insights Study sponsored by Virtify, “Managing Paper at Its Roots: Extending Beyond Document Management to Enterprise Content Compliance,” IDC #HI222097, February 2010.

 

About Virtify

Virtify is the market leader in Enterprise Content Compliance software solutions for life sciences. Organizations rely on Virtify solutions to reduce time-to-market, risk, and costs by managing and automating the complex regulatory compliance and content exchange requirements throughout the product life cycle. Virtify’s easy-to-use Virtx software suite is the industry’s only solution to provide a secure, collaborative web-based environment for managing regulated content throughout the entire continuum – from pre-clinical through product registration to commercialization. The company plays a leadership role in the development of global regulatory standards and is an active participant in a variety of standards committees. Virtify’s software products combined with comprehensive professional services and deep domain expertise enhance quality and compliance for some of the world’s leading life sciences companies. Located on the Web at www.virtify.com

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