News - Axendia to Present Analysis on Future of FDA’s Electronic Interactions with Regulated Industry at 2008 Master’s Summit

Yardley, PA and Salt Lake City, UT, September 4, 2008 – Axendia Inc., a trusted advisor to life science executives on business, technology and regulatory strategies, and MasterControl Inc., a global provider of GxP process and document management software solutions for life science companies, today announced that Axendia will present findings and analysis on the recently completed study identifying key shifts in the FDA’s organizational and technology infrastructures aimed at facilitating electronic interactions with regulated companies. The session will be presented at MasterControl’s 2008 “Master’s Summit” on September 18, 2008, in Snowbird, Utah.

Historically, interactions between the FDA and life science manufacturers have required the creation and dissemination of reams of paper documents for review, approval and audit.
Over the last few years, the FDA has recognized the need to foster electronic interactions with the organizations it regulates. To that end, the FDA has formed the “BioInformatics Board” to oversee the planning and control of the administration’s bioinformatics initiatives and to ensure that these activities are communicated to all levels of the FDA.

“Initiatives being implemented under the auspices of the FDA’s BioInformatics Board will have a transformational effect on future interactions between life science manufacturers and the FDA," commented Daniel R. Matlis, President and Founder of Axendia. "During the session, we will present findings and analysis of the study and the potential impact of the FDA’s shift to electronic interactions on regulated companies.”

The session will cover:

  1. FDA’s Bioinformatics Board charter, its role and structure
  2. Strategic framework for FDA business automation initiatives
  3. Information technology initiatives currently underway
  4. Regulatory policies and procedures supporting Bioinformatics Board initiatives
  5. Data standards enabling Bioinformatics Board initiatives
  6. 21 CFR § 11 update

About Axendia Inc.
Axendia Inc. is a leading strategy consulting and analysis firm focused on the life sciences and healthcare markets. The firm provides trusted advice to life science executives on business, regulatory and technology issues. Axendia's unique perspective is a result of our focus on the life sciences and healthcare markets and a unique blend of industry experience and strategic vision. This approach enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia can be found at

About MasterControl Inc.
MasterControl Inc. has been at the forefront of providing document management and GxP process solutions to life sciences companies since 1993. Hundreds of companies around the world rely on MasterControl to automate and effectively manage their GxP processes. The MasterControl solution is easy to use, deploy, validate, and maintain. MasterControl incorporates industry best practices for automating and connecting every stage of the product development cycle. By combining an integrated platform with a continuum of risk-based software validation products, implementation services, training and technical support, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. For more information, visit the MasterControl website, or call 800-825-9117.