Taratec’s Compliance to Secure Discovery Labs Clinical Trial Data
Taratec has licensed its Part 11 compliance software, Taratec e-Compliance (TeC), to Discovery Laboratories, Inc. to secure key clinical trial data. Discovery Laboratories is a specialty pharmaceutical company headquartered in Doylestown, PA that develops respiratory therapies and pulmonary drug delivery products. Discovery Labs has purchased a multi-user software license for TeC, which Taratec is in the process of implementing and validating.
TeC, now in Version 2.0, is an add-on, scaleable product designed to address the FDA’s electronic records and signatures rule, 21 CFR Part 11 without any changes to existing technology infrastructure. Using the industry-standard Oracle(r) platform, TeC secures all regulated data files found throughout life science organizations from their point of creation into a single, centrally controlled repository.
“This contract demonstrates the marketplace’s confidence in TeC’s ability to address 21 CFR Part 11 in a time-efficient, seamless manner,” said Teresa F. Winslow, president and COO of Taratec. “We look forward to helping Discovery Labs leverage TeC as part of its approach to the business-critical FDA submission process.”