Biosero Receives FDA 21 CFR Part 11 Compliance Certification for Green Button Go Laboratory Automation Software
San Diego, CA -8/24/2018 Biosero, a premiere developer of software and integrated solutions to automate laboratory workflows, announced today completion of FDA 21 CFR Part 11 compliance certification for their Laboratory Automation Software package, Green Button Go.
Biosero worked with the Arbour Group, an independent global regulatory solutions organization serving the Life Sciences industry, to complete the validation and compliance for GBG software. This certification assures capabilities exist in GBG software to enable customers and partners to achieve Food and Drug Administration (FDA) 21 CFR Part 11 compliance for their specific solutions. The compliance enabling process included verification of system functionality, audit trails, electronic signatures, and other documentation required when using electronic quality records.
Prabhakar Henry, Manager of Software Development at Biosero commented, “Our CFR 21-11 compliance capability in Green Button Go (GBG) will provide customers in a regulatory environment utilizing potentially complex automation requirements with the ability to improve their processes. We are addressing additional compliance metrics and adding other key features in GBG that are critical to many of our customers moving forward in a significantly more data-driven life science community.”
Tom Gilman CEO of Biosero commented, “Meeting the (FDA) 21 CFR Part 11 compliance standard will immediately help our expansion into the clinical diagnostic markets. We are very excited to continue to raise the bar on our software products and integration capabilities.” Remarking on the future of GBG, Gilman stated, “We will be releasing additional products in the near future that will allow scientists to capture and leverage significantly more data from multiple sources, ultimately helping them make better data-driven decisions.”
About Biosero: Biosero supports the world’s leading life science scientists with robotics, devices and data WorkCell integrations for drug discovery and development. Our leading laboratory automation scheduling software “Green Button Go”, is operator friendly for simple to complex automation platforms and experiments utilizing the most current technologies for standard or custom systems.
Biosero, Tom Gilman, CEO Phone: 858-880-7376
Address: 9560 Waples Street, San Diego, CA, 92121