Quality and Compliance
Lower your cost of compliance
REPORT YOUR DATA WITH CONFIDENCE
The Elemental Machines system can reduce your cost of staying compliant by auto-generating traceable and auditable reports that are compliant with 21 CFR Part 11. Pre-formatted templates allow you to quickly incorporate the data you need for your internal Quality Management System.
FDA 21 CFR 11 compliance requires that a system meets certain controls to ensure data integrity, accessibility, and confidentiality of electronic records. Elemental Machines Insights platform:
- Meets Data Integrity requirements: 21 CFR Part 11 requires that data be stored redundantly, regularly backed up, and recorded with a system generated timestamp, checksum and audit trail. Elemental Machines sensor data is encrypted in transit using HTTPS protocol, redundantly stored, and is not able to be modified by users once recorded. All data is recorded with a timestamp and data validity is verified upon ingestion, storage and thereafter. Data is stored by Elemental Machines without limit in time or quantity, and is regularly backed up across distributed databases.
- Meets Data Accessibility requirements: 21 CFR Part 11 requires that human readable copies of recorded data must be available. Elemental Machines sensor data can be retrieved from a browser in the form of historical graphs and standard reports, manually exported in spreadsheet/text form, or programmatically exported using a secure API. In all forms, data is accessible to authenticated users in a readable and standard format.
- Meets Confidentiality requirements: 21 CFR Part 11 specifies that only authorized users with a unique username and password can access the system. Elemental Machines authenticates users according to this standard (or better), with a username and password as the minimum requirement, and provides roles-based access to authorized users that restricts actions to approved functions. Unauthorized users are not granted access to stored sensor data. Customer data is partitioned by account to ensure users from one customer do not see the data of another.