Meeting regulatory compliance is key for many laboratories across a variety of industries. Internet of Things (IoT) sensors, combined with data storage, retrieval and reporting capabilities, can make your job a lot easier. In this piece we highlight ways in which the use of IoT sensors can help you to achieve Good Laboratory Practice (GLP). Elemental Machines’ sensors and system are designed to be used in regulated environments by meeting FDA regulations 21 CFR Part 11B Electronic Records, 21 CFR Part 58D GLP Equipment and 21 CFR Part 1271 Human Cells and Tissues. Our sensors are factory calibrated and can be calibrated to NIST-traceable standards.
About 21 CFR Part 11B Electronic Records
Elemental Machines Platform securely collects electronic records as part of an FDA 21 CFR 11 compliant process in food, drug, medical and science-based research environments. FDA 21 CFR 11 compliance requires that a system meets certain controls to ensure authenticity, integrity, and confidentiality of electronic records. Elemental Machines Insights platform:
- Meets Electronic Record Authenticity requirements: 21 CFR Part 11 requires that the system be accurate and reliable, and give the ability to discern invalid or altered records. 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 time-stamp and data authenticity is verified upon ingestion, storage and there-after. Data is stored by Elemental Machines without limit in time or quantity, and is regularly backed up across distributed databases.
- Meets Electronic Record Integrity requirements: 21 CFR Part 11 requires that human readable copies of records can be generated while protecting the original record. Elemental Machines sensor data can be inspected from a browser in the form of historical graphs, time-stamped copies generated in standard reports, and data 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 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.
Note: In order to be completely 21 CFR Part 11 compliant, an organization’s entire system of data collection and recording must meet regulations. This system extends beyond the use of Elemental Machines equipment to manual procedures, user training, and validation.
To learn about the other seven ways in which cloud-connected IoT sensors can help you to meet GLP, please download our free guide.