Nashua, NH (USA), April 2008 - Eedo Knowledgeware has announced that ForceTen™, its award-winning learning content management system (LCMS), is providing built-in technical controls for the U.S. Food and Drug Administration's (FDA) 21 Code of Federal Regulations (CFR), Part 11.
FDA regulations are a means to ensure that drug makers, medical-device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries document their processes and procedures to prove the integrity and authenticity of electronic documents and systems.
In learning content and knowledge management, this means using a fully configurable LCMS that employs secured electronic signatures and electronic acknowledgements in order to track and trace when learning content has been added, changed, or deleted, and by whom.
"Content management is proving to be a key challenge for companies across all industry segments, but especially in those such as aviation, life sciences, and finance, where employees must meet stringent regulatory requirements", said Josh Bersin, President of Bersin & Associates, a research and advisory firm focusing on enterprise learning and talent management.
"Today, most companies have extensive learning resources. Finding a way to efficiently manage and update these resources, track their use, and provide the reporting that meets agency requirements is a huge issue for most of the companies we talk with."
"With many of our customers in highly regulated industries, such as life sciences, banking, finance, and aviation, we have ensured our product suite supports industry standards to enable our customers to leverage Eedo for compliancy", said John Hudson, President and CEO of Eedo Knowledgeware.
"By using ForceTen, organizations can create an electronic record that helps reduce liability risk by providing a non-repudiated content audit trail. Our LCMS will track content throughout its entire lifecycle, documenting the necessary reviews, approvals, and signatures for accurate information at each stage of content development and distribution."
Eedo's suite of products supports industry standards and allows users to audit and validate the content in the system. Other standards supported by Eedo products include W3C, WCAG, WAI, Web Services, SCORM 1.2 and SCORM 2004 CERTIFIED, AICC Compliant, PENS Compliant, QTI, and Section 508 Compliant.
