The Flex lab automation is getting software to be more compliant with FDA regulations. Source: Opentrons
Laboratory automation must comply with numerous strict U.S. Food and Drug Administration regulations. Opentrons Labworks Inc. today announced its Compliance Ready Software, or Opentrons CRS, for its Flex robotic platform.
“Regulated labs have had to choose between automation they could afford and automation they could validate,” stated Opentrons CEO James Atwood. “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.”
Founded in 2013, Opentrons claimed that it “builds the execution layer for autonomous science” with open application programming interfaces (APIs). The New York-based company added that its robots standardize biological experimentation for drug discovery, genomics, and diagnostics, enabling continuous learning between AI models and physical laboratories.
Backed by SoftBank and Khosla Ventures Opentrons said it has deployed more than 10,000 systems, including installations at every Top 20 U.S. research university and 14 of the top 15 global biopharma companies.
Opentrons makes liquid handling compliant, accessible
Regulatory scrutiny of electronic records and data integrity continues to intensify across pharmaceutical research and development, biotechnology discovery, GLP (good laboratory practice), and GCP (good clinical practice) environments, noted Opentrons. ALCOA+ expectations, sustained enforcement on FDA Title 21 CFR Part 11 electronic records controls, and growing pressure to automate preclinical and discovery work under flat R&D budgets have left regulated labs with difficult trade-off, it added.
Labs can deploy expensive enterprise automation that they can validate, or they can rely on accessible platforms that cannot be used in regulated workflows at all, Opentrons said. Many regulated workflows are still run manually, completed over budget, or skipped entirely.
In response, the company has designed Opentrons CRS for an accessible benchtop liquid handling platform and to comply with 21 CFR Part 11. The system brings authentication, signed audit trails, role-based access, and electronic record integrity to Flex. Opentrons said this gives regulated labs an audit-ready automation option at a total cost of ownership (TCO) about five times lower than GxP liquid-handling systems.
Submit your session idea for the 2026 RoboBusinessCRS provides features for Flex
While each lab is responsible for introducing and validating compliant workflows in its own environment, Opentrons said that CRS provides the technical foundation that regulated labs need to deploy Flex in compliance-ready operations:
- Authentication, role-based access, and signed electronic audit trails aligned with 21 CFR Part 11 requirements that record every action, bind it to an authenticated user, and produce records aligned to ALCOA+ data integrity expectations
- Electronic record integrity enforced at the system level rather than through software add-ons that can be bypassed
- Hardened operational controls that disable interactive remote interfaces, routing all activity through governed, audited pathways
- Per-robot activation that is irreversible once enabled, keeping a Flex configured for regulated workflows in a known compliance-ready state
- No change to the scientist workflow, keeping existing protocol authorship tools and run management via the Opentrons App
- Local data retention, with records being stored and managed by each lab directly on each instrument
Opentrons CRS is designed for non-GMP (good manufacturing practices) regulated environments, including pharma and biotech R&D, discovery and preclinical operations, and contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) running non-GMP services. It can also help GLP and GCP laboratories, as well as medical device manufacturers’ R&D and design verification teams.
The company said Opentrons CRS can be enabled on any of its Flex robots anywhere in the world. The software will debut at Booth 208 at SLAS Europe 2026, with one-on-one demonstrations of CRS on the Opentrons Flex available by appointment.
Attendees can experience authorized user login and protocol launch on Flex, with each action recorded in the signed, immutable audit trail that underpins 21 CFR Part 11 readiness.
Opentrons Compliance Ready Software will be generally available to customers in August 2026.
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