Quality and Compliance

Regulatory
Compliance

10 tips for using IoT sensors for compliance

compliance simplified

Continuous data collection via IoT sensors and data storage in the cloud offers the best balance between data security and access for regulatory compliance.

Meeting regulatory compliance

Our 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.

Numerous industries are regulated by government agencies or by working groups such as ASTM or the American Petroleum Institute. These regulated industries typicallymust provide data to prove they comply with industry-specific regulations.

 Industries that  are regulated by the Food and Drug Administration, must comply with 21 CFR Part 11B regulations regarding electronic records. Our sensors and platform help our customers comply with these regulations and with Good Laboratory Practice (GLP).

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 data integrity, accessibility, and confidentiality of electronic records. Elemental Machines Insights platform:
    • Meets Data Integrity requirements: 21 CFR Part 11requires that data be stored redundantly, regularly backed up, and recorded with a system generated timestamp, checksum and audit trail.  Elemental Machines sensor datais encrypted in transit using HTTPS protocol, redundantly stored, and is not able to be modified byusers 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 limitin 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 beavailable. 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.
  • 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 extendsbeyond the use of Elemental Machines equipment to manual procedures, user training, and validation.
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21 CFR Part 58D GLP for Lab Equipment

  • Elements & Dashboard features are designed to report temperature and environmental data for customer’s study protocol in a variety of methods: dashboard view, logfile export, PDF report, API.
  • Wireless Elements can be attached in a variety of ways (no-tool magnetic attachment, removable adhesive strips, etc.)  that affordsaccess for inspection, cleaning and maintenance.
  • Elements are factory calibrated, available with NIST-traceable calibration, and can be easily be calibration verified in-field.
  • Detailed product sheets describing inspection, cleaning, maintenance, testing, calibration for sensor Elements are available.
  • Element and platform operation and troubleshooting information is available online and through customer support.
  • Elemental Insights dashboards provides dedicated, traceable fields for calibration date, installation date and other user operations including documentation of non-routine repair and corrective actions. These can be exported via reports into a customer’s QMS system.

21 CFR Part 1271 Human Cells, Tissues, and Cellular & Tissue-based Products

  • The Elemental Machines sensors and platform can be used in support of compliance with FDA 21 CFR Part 1271.
  • Meets Alerts & Monitoring requirements:  
    • Elemental Machines sensors and platform can be used to continuously monitor, document, and maintain records of, monitoringactivities in freezers, refrigerators, cold rooms, and other storage areas.
    • Alert thresholds can be set to pre-defined acceptable limits and proactively notify when exceeded, creating an audit trail and capturing related corrective actions.
    • Cloud-based storage provides sufficient readable access in excess of 10 years.
    • The Elemental Machines system stores and can reproduce electronic records on demand through log download and reports.
  • Meets System for User Generated records requirements:
    • The Elemental Machines system provides annotation fields that allow users to document cleaning, disinfection, maintenance and inspection activities related to Elemental Machines sensors. This information can be collected into Reports ready to enter into the customer’s QMS system.

Food Safety

Cold Storage - FoodOne of the most important FDA regulations related to food safety is the Food Safety Modernization Act (FSMA) which aims to prevent food safety problems before they occur, rather than reacting to them after they occur. The reason behind this is quite simple: Prevention is more cost-effective than reaction. One of the simplest ways to prevent food safety problems is to diligently monitor cold storage temperatures. There are several tools that food manufacturers and food service companies can use to do this. We highlight some of the common tools and provide a comprehensive evaluation of each method.

There are essentially four choices for monitoring freezer/fridge temperatures:

  • Manual thermometers
  • Chart recorders
  • Data Loggers
  • Wireless IoT devices
Download our E-guide to learn the pros and cons of each technique. (link to landing page)

 

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