21CFR Part 11

Effective August 20, 1997 The Food and Drug Administration added Part 11 to Title 21 of the Code of Federal Regulations. As a basic principle it states:

"The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper."

Consequently, the collection, storage, and retrieval of electronic data records in the FDA regulated industries have become business-critical tasks. As companies struggle to comply with 21CFR Part 11 and in support of the industry's efforts to move from traditional paper-based to electronic-based data management, effective implementation of e-record management systems has become a strategic goal.

Innovatum, Inc. has developed and implemented a product named DataThread™ that is aimed at satisfying the need for collecting e-records and e-signatures and for storing auditable files of this data. Additionally, DataThread™ has significant capabilities for oversight, and supervisory approval of any change to business critical data elements.