US Food and Drug Administration's CVM laboratory implements search, retrieval, and archiving system to meet CFR Part 11 requirements
Scientific Software supplier of informatics and analysis solutions to the scientific community, has announced that the US FDA CVM laboratory, located in Laurel, Maryland, is implementing its Cyberlab knowledge engineering system.
Cyberlab will allow the FDA to have automated collection, management, and archiving of its electronic records.
Cyberlab will also assist the agency in achieving its own Part 11 regulatory requirements for electronic records and electronic signatures.
"We are very excited that the FDA CVM has chosen Cyberlab," said Soheil Saadat, president and CEO of Scientific Software.
"After extensive review of different vendors, they determined that Cyberlab was the best solution to meet their requirements." The company says that Cyberlab is the industry's first web-based system designed to capture and maintain all the electronic records across the enterprise.
Users can search, retrieve, and archive any type of an electronic record of any size.
Designed with US 21 CFR Part 11 in mind, Cyberlab assists organisations to become compliant with this new regulation.
Built using standard web technology, Cyberlab is expandable from single user system to global multi-site implementations.
