21 CFR Part 11 Compliance for Electronic Records

Organizations increasingly rely on computer-based technologies for their R&D and manufacturing processes. Data from these technologies is electronically captured, analyzed, and maintained. The FDA provides compliance requirements under 21 CFR Part 11 for electronic data collected by all industries that fall under its jurisdiction. These requirements align will OECD (Organization for Economic Cooperation and Development) initiatives.  The intention of both is to help ensure that the electronic data collected is trustworthy, reliable, and equivalent to paper records.  

Many Elemental Machines customers are in industries regulated by the FDA.  Thus, these organizations are subject to 21 CFR Part 11 compliance. Important requirements and attributes of the Elemental Machines Sensory Network solution that demonstrate 21 CFR Part 11 compliance are described below:

  • Audit Trail:  This feature ensures that user activity on the system is recorded.  This includes user logins and changes made to critical parameters that could impact process outcomes. Often users may create modify, or delete records as a part of their routine workflows. Such activity should be time-stamped to clearly identify the sequence of events and users responsible for those activities. The Elemental Machines Insights Dashboard can auto-generate 21 CFR Part 11 compliant reports that include time-stamped Element readings, alerts details such as alert thresholds, communications, and more.  
  • User Management:  This feature ensures that only authorized users have access to electronic data. Furthermore, users must be granted appropriate permission levels, eg. permissions to generate and modify workflows/data vs. merely view workflows/data.  Access to data collected by the Elemental Machines Sensory Network Solution is available through user login with secure password requirements. Additionally, role-based permissions ensure that only authorized users are permitted to change settings for critical process parameters.
  • Data Security:   This requirement ensures the accuracy, reliability, and authenticity of the electronic data.  Data collected through the Elemental Machines Sensory Network system is protected through SSL encryption.  Additionally, data measurements are non-editable. Lastly, all measurements and events details are time-stamped to ensure data integrity.  Thus, users can be confident that the fidelity of the data will be maintained in electronic format.
  • User Signatures:  Some important criteria for user signatures on quality documents are the identity of signatories and the indication for the signatures (ie. authorship, approval, etc.)  The cover page of the machine reports produced by Elemental Machines displays these parameters for easy integration of electronic records into existing quality management systems.

 

Technological advances will continue to shift workflows from paper-based to paperless. Similarly, FDA requirements for electronic data will continue to evolve.  It is expected that electronic records that are 21 CFR Part 11 compliant will become the standard of tomorrow. Elemental Machines is proud to provide 21 CFR Part 11 compliant solutions today and to include this requirement for future products.