Image Studio™ 21 CFR Part 11 software supports controlled image acquisition, secure data handling, and traceable analysis workflows aligned with FDA regulatory requirements.
In FDA-regulated environments, electronic records must be trustworthy, traceable, and inspection-ready. Image Studio 21 CFR Part 11 is designed to help laboratories address the technical requirements of Title 21 CFR Part 11, including audit trails, user access control, electronic signatures, and secure data handling.
Image Studio 21 CFR Part 11 software builds on the powerful acquisition and analysis capabilities of the standard
Image Studio, adding the controls that regulated labs require – from access restriction to traceable audit logs.
Restrict system access to authorized personnel with secure logins and role-based permissions.
Automatically record who did what and when, creating a complete trail of actions for inspection or review.
Capture identity-linked approvals that support compliant record workflows.
Maintain authoritative versions of images and results to support regulatory review.
Store data on your validated server environment, separate from client workstations, to reinforce data integrity.
Regulated labs don't have to sacrifice analytical capability for compliance. Image Studio 21 CFR Part 11 delivers the same robust acquisition and analysis functionality trusted by researchers – while adding the technical controls needed for regulated workflows.
Export traceable, audit-ready data while preserving system controls and user attribution.
Maintain consistent, review-ready experiment documentation linked to authenticated users and controlled workflows.
Standardize acquisition parameters to reinforce SOP adherence and reproducibility.
Our regulatory product experts can help with installation, configuration, and integration to ensure Image Studio 21 CFR Part 11 is deployed according to your lab's standard operating procedures. Systems installed by our regulatory product experts include coordinated upgrade support to help maintain validated environments over time.
Get the full 21 CFR Part 11 Compliance Guide to learn how Image Studio supports regulatory requirements and how it may fit within your validation strategy.
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