Quality and Compliance

Data
Traceability

Security, accuracy, reliability and authenticity are some of the benefits of continuous electronic data collection and storage. Our systems do this for you, with no user intervention, 24/7.

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

Data you can count on

FDA 21 CFR Part 11

Audit Trail 

This feature records user activity on the system and givescustomers ‘the ability to discern invalid or altered records’.  Often users may create, modify, or delete records as a part of their routine workflows. The Audit Trail includes user logins, changes made to critical parameters that could impact process outcomes and time-stamping to clearly identify the sequenceof events and users responsible for those activities.

Record Generation

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 platform 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 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.

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