goBalto Completes a Successful FDA 21 CFR Part 11 Compliance Audit
SAN FRANCISCO, Jan. 11, 2012 /PRNewswire/ -- goBalto, developer of new generation web-based clinical research solutions, announced that it successfully completed a FDA 21 CFR Part 11 compliance audit of its goBalto TrackerTM Software-as-a-Service (SaaS) clinical trials application. Tracker's successful audit will help both sponsors / clinical research organizations and investigator sites running clinical trials comply with FDA rules and regulations governing electronic records and electronic signatures.
"The Tracker application demonstrated compliance with the current 21 CFR Part 11 industry standards feature set for security, data transfer, audit trails, and electronic signatures. No deficiencies were found. The implementation of security and electronic signature components is elegant and sets a new standard for web-based GxP applications," said David Nettleton, principal at Computer System Validation, who conducted the audit.
goBalto and David Nettleton found innovative ways to balance 21 CFR Part 11 compliance requirements with cutting-edge Agile software development practices, facilitating rapid response from the feedback of clinical trial professionals.
goBalto is a developer of new generation web-based solutions that simplify how clinical trials are conducted in the pharmaceutical, biotechnology and medical device industries. TrackerTM, launched in June 2011, is the first purpose-built Software-as-a-Service clinical research tool that enables clinical trials sponsors and clinical research organizations to collaborate with multiple partners directly from the web in a transparent and regulatory compliant manner. Founded in Silicon Valley in 2008 by biotechnology industry veteran Jae Chung and backed by leading health technology investors, goBalto applies Agile and lean startup methodologies to building technological solutions that address evolving global healthcare. Visit www.gobalto.com for more information.
About David Nettleton:
David Nettleton, principal at Computer System Validation, is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. His most popular book is Risk Based Software Validation - Ten easy Steps (Davis Horwood International and PDA - www.pda.org, 2006), which provides fill-in-the-blank templates for completing a COTS software validation project. He has completed more than 205 mission critical laboratory, clinical, and manufacturing software implementation projects.