Enhanced FDA reporting, full IQ/OQ package & incubator monitoring sensor
round out Lab 21 offerings
A national leader in temperature and environmental monitoring serving the research and laboratory industries is introducing an enhanced suite focused on better serving the life science professional focused on compliance automation and asset protection.
Sonicu, which serves scores of public and private laboratories and research-intensive universities across North America, is improving its ability to serve their exacting Food and Drug Administration regulatory needs with its Lab21 offering.
Lab21 represents a significant upgrade in delivering affordable and simple monitoring and compliance services, including:
- Enhanced software features to comply with FDA 21 CFR Part 11 requirements
- Group reports and the ability to have users all be able to comment/review/approve reports with cover sheets
- Strict personnel controls and enhanced audit trails required by the FDA
- Rapid alarm and notification testing with SoniCloud Validation Alarm feature for PQ compliance
- A password allowing users to time-stamp who and when specific actions are executed
- Double-verification, compliant with 21 CFR Part 11, for significant changes to the system settings
- Full probe calibration history and regularly updated monitoring system health reports
- Access restriction to unauthorized users, device check performance and support written procedures and system documentation which are all required for full compliance
- White glove IQ/OQ offering to help customers streamline implementation
Joe Mundell, Chief Revenue Officer, Sonicu, said the new offering reflects significant growth in the life science industry around protecting their research and complying with increasingly strict regulatory requirements.
“Lab21 represents feedback from dozens of customers who request more sophisticated monitoring and regulatory reporting to support their research,” Mundell said.
“We’ve worked closely with our customers to develop the features and functionality they need to work more efficiently and stay compliant.”
When coupled with the Sonicu Incubator Monitoring sensor, which includes temperature, humidity and CO2, the new package is ideal for laboratory or life science applications.
The incubator monitor installs in minutes and configures simply into the SoniCloud software, providing real-time and historical visibility to help researchers validate their work and remain compliant with Food and Drug Administration guidelines.
When combined with our robust suite of temperature monitoring solutions, which ranges from cryogenic and Ultra Low temperature through ambient and high heat, Sonicu offers labs and life science organizations the opportunity to consolidate their monitoring, protect their perishable assets and automate tedious regulatory reporting.
All Sonicu monitoring systems can be supported with our SNAP calibration program which automates the NIST calibration process, delivering another layer of compliance simplicity.
When coupled with the robust IQ/OQ service, Sonicu has the ability to help more labs with superior compliance readiness.
IQ and OQ protocols are methods for showing that the equipment being used or installed will deliver a high degree of assurance so production processes will consistently manufacture products that meet quality requirements.
Installation Qualification (IQ) verifies that the equipment being qualified has been installed and configured according to the manufacturer’s specifications or installation checklist.
Operational Qualification (OQ) involves identifying and inspecting equipment features that impact product quality.
Scores of laboratories and similar organizations, including the Ohio University Innovation Center, Xytex Sperm Bank and MiraVista Diagnostics, rely on Sonicu for their temperature and environmental monitoring.
