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OVERVIEW

Be Audit-ready with Opentrons

Compliance Ready Software delivers the technical controls for 21 CFR Part 11. Your SOPs and validation practices do the rest.

Introducing Compliance Ready Software

What Compliance Ready Software Provides: The technical controls 21 CFR Part 11 mandates – authentication, audit trails, access controls, and electronic record integrity – are built into the platform.

What Your Team Brings: The SOPs, validation protocols, and data management practices that operationalize those controls in your workflow. We can you help build them.

Bring Flex into Regulated Environments

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    Designed for Full User Accountability

     

    • Role-based permissions define what each user can operate, modify, or access
    • Shared accounts are structurally prevented; every interaction requires unique credentials

     
     

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    Validated system controls

     

    • Compliance mode is irreversible once activated; SSH and Jupyter access are permanently disabled
    • Only administrators can modify system configuration or security policies

     
     

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    Secure audit trails

     

    • Every run automatically logs who acted, what ran, and when
    • Records cryptographically signed and tamper-proof
    • Logs are retained in full and available for FDA
    inspection at any time

     
     

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    Electronic record integrity

     

    • Every record is linked to the individual who created or approved it
    • Records cannot be copied, transferred, or altered
    • All records remain readable and retrievable for FDA inspection for their full retention period

Regulated labs demand more than automation

Regulated labs require proven user accountability, full traceability of every action, protection against unauthorized changes, and audit-ready data integrity. Without these controls, automation systems are excluded from GLP and GCP environments.