NetDimensions Launches New Version Enterprise Knowledge Platform To Help Pharma Companies Comply with FDA Regulations

  • Date: December 09, 2010
  • Source: Admin
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The Enterprise Knowledge Platform (EKP) from NetDimensions has updated a new version 6.3 of its learning management system. NetDimensions is a global provider of performance, knowledge, and learning management systems. The primary products developed by the company are the Enterprise Knowledge Platform (EKP), the Enterprise Assessment Platform (EAP) and the Enterprise Content Platform (ECP).

Pharmaceutical companies will benefit with the new EKP 6.3 functionality, which ensures compliance with the U.S. Food and Drug Administration's (FDA) Code of Federal Regulations Title 21, Part 11, more commonly known as 21 CFR Part 11. New features include enhanced appraisal functionality, user-configurable EKP homepage, and support for Adobe Acrobat Connect Pro.

"21 CFR Part 11 involves U.S. FDA requirements with regard to electronic signatures and audit reports in the highly regulated healthcare, pharmaceutical and medical device industries," explains Bejcek, Senior Manager for Product Marketing, NetDimensions.

The company aims to enable streamlining compliance pharmaceutical organizations processes through the EKP features to get 21 CFR Part 11 certification, keeping in line with NetDimensions' own focus toward regulatory compliance and certification.

21 CFR Part 11

Title 21 CFR Part 11 deals with FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable, and equivalent to paper records.

FDA’s Center for Drug Evaluation and Research (CDER) rolls out in 2011, with the aim to inspect compliance to the regulation under 21 CFR Part 11 during its inspections.

Part 11 obligates biotech companies, drug makers, medical device manufacturers, biologics developers, and other FDA-regulated industries, (exceptions exist), to implement certain measures/controls in the processing of electronic data that are (a) required to be maintained by the FDA predicate rules or (b) used to demonstrate compliance to a predicate rule. All data submitted to the FDA in electronic form fall under this rule. Paper submissions in electronic format (e.g. faxes) do not come under this rule.



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