IMPORTANT NOTICE

The 21 CFR Part 11-compliant computerized imaging solutions (hardware and software) that are offered by Olympus in conjunction with Soft Imaging System and BioMedion are designed to provide all technical features that are needed to operate a computerized system in compliance with FDA regulation 21 CFR Part 11 (Electronic Records; Electronic Signatures; Final Rule) and other predicate rules like GLP, GCP and cGMP.

For each laboratory and/or user intending to operate a computerized system in compliance with 21 CFR Part 11 or any other FDA predicate rule, it is important to understand that full compliance requires a number of policies and procedures to be in place in that particular laboratory or department, in addition to the technical solutions that the Olympus systems provide.

These additional measures include

For a full assessment of the particular requirements in your laboratory, please contact your internal Quality Assurance Department or refer to FDA regulation 21 CFR Part 11 or other applicable FDA predicate rules.

If you have additional questions about operating Olympus microscope imaging systems in compliance with 21 CFR Part 11, please contact our partner, BioMedion Inc.