Quality and Compliance
Unlock the Power of your data
Learn how our connected platform can help you with GxP compliance. NIST-traceable sensors, field calibration, audit reports and IQ/OQ procedures help pharma customers comply with Good Manufacturing Practices (GMP).
10 ways IoT sensors help to enable GLP
Data is the lifeblood of many organizations. Quality management systems and industry regulations often require copious amounts of data that is reliable and easily retrieved. For example, vaccine manufacturers are required to maintain five years of daily temperature records for vaccine storage, which can be easily automated by capturing these readings automatically with the Elemental Machines platform.
Good Manufacturing Practice (GMP) is a system for ensuring that products are manufactured and tested in accordance with quality standards. GMP is intended to minimize the risks involved in pharmaceutical production from the starting materials, facilities, equipment and training of staff. Detailed, written procedures are required for all processes that could affect the final product.
To help our customers follow GMP, Elemental Machines has made a number of significant enhancements to our products and procedures, such as offering NIST-certified sensors, field calibration of sensors, installation qualification and operational qualification (IQ/OQ), and enhanced training materials.
The FDA’s 21 CFR Part 11 establishes many requirements on electronic record keeping for industries that fall under its regulations. CFR Part 11 has requirements around audit trails, user management, data security and user signatures. If your industry is one that is regulated by the FDA, then Elemental Machines’ data collection, storage and retrieval networks will help you to comply. To learn how the Elemental Machines platform can help you comply with GLP, please check our blog.
Our IoT sensors are plug-and-play and will work with virtually any instrument, providing you with the ability to monitor a single machine or a fleet of assets spread over multiple locations. They come pre-configured to work on your network so you can start streaming data within minutes.