Quality and Compliance
For consistent results monitor temperature, humidity, pressure and light
using IoT to enable GMP
NIST-traceable sensors are available for an additional fee. Most of our customers are satisfied with sensors calibrated in-house to NIST standards. For GMP facilities sometimes this is not sufficient. Some customers also require NIST-traceable calibration from an ISO 17025 accredited facility. We can accommodate these requests and provide certification of testing.
GMP facilities are required to regularly check the calibration of critical sensors. Typically this would be done by an ISO 17025 certified third party. If they find a temperature sensor (for instance) that does not correlate with their reading, the customer is left with two choices – replace the sensor or calibrate it in the field. It is typically best to recalibrate and adjust the sensor in the field. This is now possible through the dashboard. Elemental Machines is pleased to partner with Essco Calibration Laboratory to provide recalibration services in the field.
The temperature reading of Element-T and Element-A sensors can be adjusted for slope and intercept based on the measurements taken during calibration. These adjustments will be stored in the settings and applied to any future readings. In addition, a reminder will be set up to check the calibration again in one year. If a different time period is desired, this can be adjusted in the dashboard.
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. Click here for more information about reports.