Carrier has launched a brand new Life Sciences model of the i-Vu® building automation system (BAS). i-Vu® for Life Sciences is an environmental management system that gives the instruments, reviews and insights to handle the crucial environments of pharmaceutical, biotech and medical machine producers in compliance with the United States Government Food and Drug Administration (FDA) regulation 21 CFR Part 11. i-Vu for Life Sciences is a solution in Carriers Healthy Buildings Program, a set of choices to assist ship more healthy, safer, extra environment friendly and productive indoor environments. Carrier is part of Carrier Global Corporation (NYSE: CARR), the main international supplier of wholesome, secure and sustainable constructing and chilly chain options.
FDA-regulated manufacturing services reminiscent of laboratories, prescription drugs, and biotech corporations require that constructing environments be exactly managed to keep up environmental circumstances reminiscent of temperature, humidity, strain and airflow. Carriers i-Vu for Life Sciences carefully screens and controls these crucial parameters, serving to preserve the standard and consistency of the merchandise created inside these services. The 21 CFR Part 11 regulation requires that the efficiency of the i-Vu system be documented and validated utilizing digital information and signatures and that operator authentication, authorization and exercise inside the BAS be managed and monitored securely.
Our new i-Vu for Life Sciences system helps present prospects with the boldness that their manufacturing atmosphere is producing prime quality merchandise whereas additionally serving to to eradicate product waste, mentioned Mark Jones, enterprise supervisor, Controls, Carrier. An automated alarm will alert if one thing goes improper, so prospects can reply earlier than the manufacturing course of is affected. And digital information assist be sure that they preserve compliant with 21 CFR Part 11 necessities.
i-Vu for Life Sciences additionally addresses the safety necessities related to FDA-regulated manufacturing. A devoted server may be situated securely inside any facility, whereas multi-use services can use a number of or separate servers. Each server can reside on a corporations present Intranet and host a single, safe database. These servers make the most of Secure Sockets Layer (SSL) 128-bit encryption, BACnet whitelist firewall and superior safety password insurance policies. Operator logins can be managed securely utilizing LDAP or Active Directory.
i-Vu for Life Sciences additionally requires operator signature and remark to acknowledge crucial alarms, whereas monitoring and documenting all procedural actions. Any tried change to crucial environmental controls prompts person verification, together with the digital recording of the rationale for the change in a safe audit log. To confirm exercise, system directors can simply question the systems database by operator, location or date. A strong reporting engine additionally generates digitally signed and permitted compliance reviews.
i-Vu for Life Sciences additionally helps many commonplace options, together with vector flooring plan graphics, customizable dashboards/graphics/developments/reviews, and the power to combine third-party sub-systems and software program utilizing BACnet®, Modbus®, and LonWorks® protocols.
Founded by the inventor of contemporary air con, Carrier is a world chief in high-technology heating, air-conditioning and refrigeration options. Carrier consultants present sustainable options, integrating energy-efficient merchandise, constructing controls and vitality providers for residential, industrial, retail, transport and meals service prospects. Carrier is part of Carrier Global Corporation, the main international supplier of wholesome, secure and sustainable constructing and chilly chain options. For extra info, go to carrier.com or comply with Carrier on LinkedIn.
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