{"id":19021,"date":"2020-06-23T11:11:52","date_gmt":"2020-06-23T15:11:52","guid":{"rendered":"https:\/\/avtech.com\/articles\/?p=19021"},"modified":"2023-12-15T12:20:27","modified_gmt":"2023-12-15T17:20:27","slug":"room-alert-complies-with-fda-cfr-21-regulations","status":"publish","type":"post","link":"https:\/\/avtech.com\/articles\/19021\/room-alert-complies-with-fda-cfr-21-regulations\/","title":{"rendered":"Room Alert Complies With FDA CFR 21 Regulations"},"content":{"rendered":"\n<div class=\"wp-block-image\"><figure class=\"alignleft size-large is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/Food_and_Drug_Administration_logo.svg_-1024x422.png\" alt=\"\" class=\"wp-image-19025\" width=\"148\" height=\"61\" srcset=\"https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/Food_and_Drug_Administration_logo.svg_-1024x422.png 1024w, https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/Food_and_Drug_Administration_logo.svg_-300x124.png 300w, https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/Food_and_Drug_Administration_logo.svg_-768x317.png 768w, https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/Food_and_Drug_Administration_logo.svg_.png 1280w\" sizes=\"(max-width: 148px) 100vw, 148px\" \/><\/figure><\/div>\n\n\n\n<p><span style=\"font-weight: 400;\">The U.S. Food and Drug Administration (<\/span><a href=\"https:\/\/www.fda.gov\/\"><span style=\"font-weight: 400;\">FDA<\/span><\/a><span style=\"font-weight: 400;\">) title 21 was recently revised in April of 2019. Room Alert meets FDA CFR 21 regulations that must be followed by restaurants, medical facilities, food storage, warehouses and more. Now that environment monitoring and environmental control is required to ensure <\/span><a href=\"https:\/\/avtech.com\/articles\/16216\/national-food-safety-month-with-room-alert\/\"><span style=\"font-weight: 400;\">food safety<\/span><\/a><span style=\"font-weight: 400;\"> for employees, customers and the overall public, Room Alert is the ideal solution for your restaurants, food processing plants and more. Conditions that now need to be tracked include temperature and humidity, ventilation and air filtration and more. Regulating air quality helps businesses monitor for air pollutants, dust particles and other forms of contamination that can compromise the safety of <\/span><a href=\"https:\/\/avtech.com\/articles\/16487\/food-warehousing-101-why-you-need-environment-monitoring\/\"><span style=\"font-weight: 400;\">food warehousing<\/span><\/a><span style=\"font-weight: 400;\"> or other products.<\/span><\/p>\n\n\n\n<h3><b>What are the FDA regulations?<\/b><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">According to the <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=1271.195\"><span style=\"font-weight: 400;\">FDA<\/span><\/a><span style=\"font-weight: 400;\">, \u201cYou must monitor environmental conditions where environmental conditions could reasonably be expected to cause contamination or cross-contamination of HCT\/Ps or equipment, or accidental exposure of HCT\/Ps to communicable disease agents. Where appropriate, you must provide environmental monitoring for microorganisms.\u201d Additionally, industries that must comply with the FDA are also required to \u201cdocument and maintain records of, environmental control and monitoring activities.\u201d Luckily, proactive environment monitoring with Room Alert is here to help!<\/span><\/p>\n\n\n\n<h3><b>Why should you trust Room Alert?<\/b><\/h3>\n\n\n\n<div class=\"wp-block-image\"><figure class=\"alignright size-large is-resized\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/avtech.com\/articles\/wp-content\/uploads\/2020\/06\/EQm2CL4WkAE1raw.png\" alt=\"\" class=\"wp-image-19023\" width=\"196\" height=\"74\"\/><\/figure><\/div>\n\n\n\n<p><span style=\"font-weight: 400;\">AVTECH is the market leader in \u201cIT &amp; Facilities Environment Monitoring\u201d and Room Alert is the most popular product for proactive environment monitoring worldwide. We offer all the monitors, sensors and accessories you would ever need to meet FDA environment monitoring regulations. We have over 30 years of industry expertise and countless <\/span><a href=\"https:\/\/avtech.com\/articles\/9137\/avtech-awards\/\"><span style=\"font-weight: 400;\">awards<\/span><\/a><span style=\"font-weight: 400;\"> to assure users that investing in the proper Room Alert monitors and sensors for your facility is an easy, affordable and dependable way to strengthen your business continuity plans and prevent costly downtime due to changes in your environment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">To align perfectly with the FDA requirements, we offer sensors for <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Digital_Temperature_Humidity.htm\"><span style=\"font-weight: 400;\">Temperature and Humidity<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Flood_Spot.htm\"><span style=\"font-weight: 400;\">Flooding<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Flood_Sensor_8_Cable.htm\"><span style=\"font-weight: 400;\">Water Damage<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Digital_Active_Power.htm\"><span style=\"font-weight: 400;\">Active Power<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Smoke.htm\"><span style=\"font-weight: 400;\">Smoke<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Air_Flow.htm\"><span style=\"font-weight: 400;\">Air Flow\/ Air Quality<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Room_Entry.htm\"><span style=\"font-weight: 400;\">Room Entry<\/span><\/a><span style=\"font-weight: 400;\">, <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/Motion.htm\"><span style=\"font-weight: 400;\">Motion<\/span><\/a><span style=\"font-weight: 400;\"> and so much <\/span><a href=\"https:\/\/avtech.com\/Products\/Sensors\/\"><span style=\"font-weight: 400;\">more<\/span><\/a><span style=\"font-weight: 400;\">. For higher capacity, more advanced safety and security, we recently launched our <\/span><a href=\"https:\/\/avtech.com\/articles\/17163\/advanced-security-encryption-room-alert-32s\/\"><span style=\"font-weight: 400;\">Room Alert 32S<\/span><\/a><span style=\"font-weight: 400;\"> which provides:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">HTTPS\/SSL web interface<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SSL\/TLS email notifications<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SNMP v1\/V2c\/v3<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">2048-bit encryption<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">SSL push for data to reach the Room Alert Account online portal<\/span><\/li>\n<li style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Secure and advanced alerting via email, email-to-SMS, SNMP, JSON, HTTP Post, webpage update and more<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Now with FDA regulations, businesses need to do more than implement environment monitoring. Organizations are also expected to maintain accurate and up to date records. In terms of keeping organized records to document activity, Room Alert continues to support your facilities. We offer <\/span><a href=\"https:\/\/avtech.com\/articles\/18443\/advanced-alerting-reporting-room-alert-account\/\"><span style=\"font-weight: 400;\">reporting<\/span><\/a><span style=\"font-weight: 400;\"> in Room Alert Account, our online monitoring dashboard that can be used to manage and monitor your Room Alert equipment from any internet-connected device. <\/span><span style=\"font-weight: 400;\">Reporting features in RoomAlert.com allow our users to graph their sensor data in concise and comprehensive reports to help detect trends and further prevent costly damage and downtime related to changes in the environment.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">We also understand the importance of allowing business, facilities and organizations of all kinds customize their <\/span><a href=\"https:\/\/avtech.com\/articles\/16998\/customize-the-data-retention-in-your-roomalert-com-account\/\"><span style=\"font-weight: 400;\">data retention<\/span><\/a><span style=\"font-weight: 400;\"> as noted in this article we published recently. We previously talked about how according to the FDA, <\/span><span style=\"font-weight: 400;\">\u201cAn investigator shall retain records required to be maintained under this part for a period of <\/span><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=312.62\"><b>2 years<\/b><\/a><span style=\"font-weight: 400;\"> following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified.\u201d We offer Room Alert Account plans designed to comply with FDA data retention regulations, so you can install Room Alert in your facilities and have peace of mind knowing you\u2019re meeting the necessary requirements.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Room Alert is different from other environment monitoring platforms because our Room Alert Account services are available in <\/span><a href=\"https:\/\/account.roomalert.com\/pricing\"><span style=\"font-weight: 400;\">fixed tiers<\/span><\/a><span style=\"font-weight: 400;\"> as well as fully customizable options so you can ensure your business receives exactly what you need. If your business, facility or organization must comply with FDA regulations, then the Ultimate level of Room Alert Account Services would best suit your needs.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">With Room Alert monitors starting at just $165, there is a Room Alert solution for every budget, and organizations of every size. We also have several <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=5R1YYJSwKVQ&amp;list=PL0uKYNT_hOtwO-eYF9XVp0WPgBE4uT2Ea\"><span style=\"font-weight: 400;\">industry bundle videos<\/span><\/a><span style=\"font-weight: 400;\"> that can be a helpful resource to navigate what Room Alert products would be best for your situation, such as <\/span><a href=\"https:\/\/www.youtube.com\/watch?v=1yTbW3JKz9M&amp;t=1s\"><span style=\"font-weight: 400;\">Food &amp; Beverage<\/span><\/a><span style=\"font-weight: 400;\">. Install Room Alert now and have peace of mind tonight that you\u2019re meeting industry regulations and getting the best proactive environment monitoring available.<\/span><\/p>\n\n\n\n<h3><b>Contact Us<\/b><\/h3>\n\n\n\n<p><span style=\"font-weight: 400;\">If you have any questions or want additional information on how Room Alert products and Room Alert Account Services comply with industry regulations, please <\/span><a href=\"https:\/\/www.youtube.com\/user\/AVTECHVideoChannel\"><span style=\"font-weight: 400;\">visit our YouTube Channel<\/span><\/a><span style=\"font-weight: 400;\">. You can email us at <\/span><a href=\"mailto:Sales@AVTECH.com\"><span style=\"font-weight: 400;\">Sales@AVTECH.com<\/span><\/a><span style=\"font-weight: 400;\"> or visit our<\/span><a href=\"http:\/\/www.avtech.com\/contact\"> <span style=\"font-weight: 400;\">Contact<\/span><\/a> <span style=\"font-weight: 400;\">page for a free consultation with one of our dedicated Senior Product Specialists today!<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) title 21 was recently revised in April of 2019. Room Alert meets FDA CFR 21 regulations that must be followed by restaurants, medical facilities, food storage, warehouses and more. Now that environment monitoring and environmental control is required to ensure food safety for employees, customers and the overall [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0},"categories":[326,20],"tags":[58,148,242,60,154,247,67,156,248,73,167,249,75,178,81,180,82,184,83,185,84,186,95,189,34,98,204,36,137,205,40,138,214,50,139,220,56,140,223,57,147,234],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<meta name=\"description\" content=\"Room Alert environment monitoring meets FDA CFR 21 regulations that must be followed by restaurants, medical facilities, food storage, warehouses and more.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/avtech.com\/articles\/19021\/room-alert-complies-with-fda-cfr-21-regulations\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Room Alert Complies With FDA CFR 21 Regulations - 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