Opentrons Launches Compliance-Ready Software for Flex Platform

Opentrons has introduced new compliance-ready software for its Opentrons Flex robotic laboratory automation platform, expanding the system’s capabilities for regulated laboratory environments requiring electronic record integrity, audit trails, and controlled workflow management.  The new Opentrons Compliance Ready Software is designed to provide technical controls aligned with U.S. FDA 21 CFR Part 11 requirements involving authentication, audit trails, role-based access control, and electronic record management for regulated laboratory operations.

The software launch reflects increasing industry focus on laboratory automation systems capable of supporting both operational scalability and regulatory data integrity requirements across pharmaceutical, biotechnology, GLP, and GCP environments.

Many regulated laboratories continue to rely upon manual workflows or significantly more expensive enterprise automation systems. This reliance is often attributed to the fact that smaller benchtop platforms have historically lacked the electronic record controls required for regulated operations.

Opentrons designs, develops, and manufactures laboratory robotics platforms and automation technologies that can be used across drug discovery, genomics, diagnostics, biotechnology, and life sciences research environments. The company’s Flex platform is a benchtop robotic liquid handling system designed to automate laboratory workflows while supporting standardized and repeatable experimental processes.

“Regulated labs have had to choose between automation they could afford and automation they could validate,” said James Atwood, CEO of Opentrons. “Opentrons Compliance Ready Software changes that equation. The Opentrons Flex becomes a platform that compliance teams can recommend, that scientists can continue using the way they already do, and that finance teams do not have to defend at five times the cost.”

The software includes authentication controls, signed electronic audit trails, role-based access management, and system-level electronic record protections aligned with ALCOA+ data integrity expectations and FDA 21 CFR Part 11 requirements.  Additional capabilities include hardened operational controls designed to disable interactive remote interfaces while routing activity through governed audit pathways, along with local instrument-level data retention and irreversible compliance-mode activation intended to maintain validated operational states.

Opentrons Compliance Ready Software is intended for non-GMP regulated environments involving pharmaceutical research and development, biotechnology discovery, contract research operations, preclinical workflows, medical device research environments, and regulated laboratory testing operations.  The platform maintains compatibility with existing Opentrons protocol development and run management workflows through the Opentrons App. Opentrons Compliance Ready Software is expected to become generally available in August 2026 and will be demonstrated publicly at SLAS Europe 2026.

About Opentrons

Opentrons develops robotic laboratory automation systems and software platforms supporting autonomous science, biological research, genomics, diagnostics, and drug discovery applications.  The company’s API-driven laboratory robotics platforms are designed to standardize and automate biological experimentation while supporting integration between AI-enabled software systems and physical laboratory operations. Opentrons reports that more than 10,000 robotic systems have been deployed globally across research universities, pharmaceutical companies, biotechnology organizations, and life sciences laboratories. For more information, please click here. 

Source/Photo Credit: Opentrons

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