Is the Bio Molecular Systems Mic and Myra Platform 21 CFR Part 11 Compliant?

21 CFR Part 11 is the section of the U.S. FDA Code of Federal Regulations that defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. Organizations using electronic systems in GMP/GLP/GCP environments must ensure their processes, documentation controls, and supporting software collectively comply with these requirements.

The Mic and Myra software includes features that support several key technical requirements of 21 CFR 11, particularly around data integrity, audit trails, and generation of human-readable records.

However, the software alone cannot make a full system 21 CFR 11 compliant. A number of requirements—such as access control, document management, user training, operational checks, and electronic signature policies—must be met by the customer’s internal QMS and IT infrastructure.

For full compliance, the Mic/Myra platform must be implemented within a validated, controlled environment following appropriate SOPs and record-management processes.

The Mic and Myra platforms provide several built-in features that support key technical elements of 21 CFR Part 11, including:

• Data integrity and tamper detection

• Human-readable electronic records

• Audit trail logging

However, full compliance requires organizational controls—including validated workflows, document management, access control, and electronic signature procedures—that are outside the scope of the software itself.

If you are operating in a regulated environment, ensure that Mic/Myra is deployed within a validated system and supported by appropriate SOPs and QMS infrastructure.