New Software Expands Automation in Regulated Labs

Opentrons Labworks, announced Opentrons® Compliance Ready Software (Opentrons CRS), a new offering for the Opentrons Flex® robotic platform. The first U.S. FDA Title 21 CFR Part 11-aligned software designed for an accessible benchtop liquid handling platform, Opentrons CRS brings authentication, signed audit trails, role-based access, and electronic record integrity to the Flex, giving regulated laboratories an audit-ready automation option at a total cost of ownership approximately five times lower than purpose-built GxP liquid handling systems.

The launch arrives as regulatory scrutiny of electronic records and data integrity continues to intensify across pharma R&D, biotech discovery, GLP, and GCP environments. ALCOA+ data integrity expectations, sustained enforcement on 21 CFR Part 11 controls, and growing pressure to automate preclinical and discovery work under flat R&D budgets have left regulated labs with a hard trade-off: deploy expensive enterprise automation they can validate, or rely on accessible platforms that cannot be used in regulated workflows at all. Many regulated workflows are still run manually, completed over budget, or skipped entirely.

“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.”

While each lab is responsible for introducing and validating compliant workflows in its own environment, Opentrons CRS provides the technical foundation that regulated laboratories need to deploy the Opentrons 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 regulated environments, including pharma and biotech R&D, discovery and preclinical operations, CROs and CDMOs running non-GMP services, GLP and GCP laboratories, and medical device manufacturers’ R&D and design verification teams. Opentrons CRS can be enabled on any Opentrons Flex robot anywhere in the world.

Opentrons Compliance Ready Software will debut at SLAS Europe 2026 at Booth #208, with one-on-one demonstrations of Opentrons CRS on the Opentrons Flex available by appointment. Attendees can experience Opentrons CRS firsthand through a live demonstration of authorized user login and protocol launch on the Opentrons Flex, with each action recorded in the signed, immutable audit trail that underpins 21 CFR Part 11 readiness. Opentrons executives will be available throughout SLAS Europe for scheduled meetings with QA, IT, lab operations, and R&D leaders evaluating compliance-ready automation for their organizations.

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