21CFR11 Manager

The 21CFR11 Manager is an extension for Biosero's Green Button Go® (GBG) Scheduler that empowers regulated laboratories to meet FDA 21 CFR Part 11 requirements for electronic records and electronic signatures (ERES). Designed for environments where compliance is non-negotiable, it integrates natively into the GBG Scheduler ecosystem to ensure that automated workflows remain traceable, secure, and audit-ready—without slowing down scientific operations or burdening lab teams.

21CFR11 Manager is built for labs operating under strict regulatory oversight, including those running single cell assays, multi-day screening protocols, or any automated workflow that requires validated, compliant execution. It provides the tools necessary to maintain compliance while preserving the flexibility that modern lab automation demands.

Key Compliance Capabilities

• Electronic signature support: Approve and verify key actions and changes through layered user authentication, satisfying ERES requirements for electronic signatures.
• Complete audit trails: Automatically generate and store detailed, timestamped records of all user and system activity across the automation environment.
• Robust user access control: Assign roles and permissions at a granular level to ensure that only authorized users can perform specific actions within the system.
• Tamper-proof logging: Safeguard critical data with logging mechanisms that ensure full traceability for compliance inspections and regulatory reviews.

Why Labs Choose 21CFR11 Manager

• Built-in compliance: Native 21 CFR Part 11 support is fully integrated into the GBG Scheduler experience, eliminating the need for separate compliance tooling.
• Designed for audit readiness: Every action taken across the automation environment can be tracked, traced, and validated to support regulatory inspections.
• No friction in workflows: Compliance standards are met seamlessly whether deploying simple or complex multi-day protocols, without creating operational bottlenecks.
• Trusted by regulated labs: Purpose-built for the most regulated laboratory environments as part of the broader GBG Scheduler platform.

Support and Resources

• Training available at your own pace
• Virtual troubleshooting assistance
• 24/7 access to the Biosero Portal
• Driver swaps to maintain system compatibility
• Easy upgrade and patch management

21CFR11 Manager integrates seamlessly as part of the GBG Scheduler ecosystem, bringing compliance capabilities to every stage of lab scheduling and execution. Biosero also provides a supporting white paper—Achieving 21 CFR Part 11 Compliance with Green Button Go® Scheduler—as well as a GBG Scheduler brochure for teams evaluating the platform.