Products and services from LI-COR Biosciences that support laboratories working under 21 CFR Part 11, including Image Studio software with audit trails and electronic signatures.
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, adding the controls that regulated labs require – from access restriction to traceable audit logs.
In Detail
Image Studio Software for 21 CFR Part 11 in detail
