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  • GMPs Don’t Sour, But Dairy Does


    Last week I started a series on Good Manufacturing Practices (GMPs) within the dairy industry, specifically ice cream. Beyond the regulations outlined in CFR 21 Part 110, producers of dairy products must also adhere to the guidelines of Part 11, the expectations for collecting, storing, and maintaining electronic records.

    CFR 21 Part 11 was implemented in 1997, but as a response to various concerns of the business community, it has been in a period of reexamination since 2003. Regardless of what may occur or change in the near future, the components of Part 11 are still relevant and enforced, and its five core requirements are validation, audit trails, legacy systems, copies of records, and record retention.

    Validation: We suggest that your decision to validate computerized systems, and the extent of the validation, take into account the impact the systems have on your ability to meet predicate rule requirements. You should also consider the impact those systems might have on the accuracy, reliability, integrity, availability, and authenticity of required records and signatures.

    Audit Trails: Persons must still comply with all applicable predicate rule requirements related to documentation of, for example, date, time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.

    Legacy Systems: The Agency intends to exercise enforcement discretion with respect to all part 11 requirements for systems that otherwise were operational prior to August 20, 1997, the effective date of part 11.

    Copies of Records: You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules.

    Record Retention: The Agency intends to exercise enforcement discretion with regard to the part 11 requirements for the protection of records to enable their accurate and ready retrieval throughout the records retention period.

    The fundamental purpose of part 11 plays an active role throughout the dairy production and distribution process. From pumping tubes to storage tanks to assembly lines to shipping containers to store shelves, dairy, whether frozen or not, passes through numerous stages of preparation and various pieces of equipment before reaching consumers’ hands, and one example of this highly involved supply chain is the procedure of pasteurization.

    Pasteurization, named after scientist Louis Pasteur, is a process that removes pathogens by way of extremely intense heat, and though there are several levels of it, the range of applied temperatures is 145-280°F with exposure times starting at fractions of a second and ending at several minutes. Too often dairy products are subjected to poor pasteurization practices or compromised environments, and when such happens, like in these historic and recent cases, consumers fall ill, companies lose money, and FDA investigators start, well, doing their job.

    Maintaining and monitoring imperative pasteurization thresholds and times is vital to the integrity of dairy products and dairy companies, and as noted, GMP regulations (CFR 21 Part 11) are in place to verify production processes and historical data. However, firms need not obsess over product and governmental mandates with the existence of proprietary and automated, cloud-based systems like Temperature@lert’s Cellular Edition and Sensor Cloud.

    Meeting or even exceeding GMPs and the standards of CFR 21 Part 11 is easier than ever with features like backup battery power, actionable email, phone, or text alerts, six-year data storage, and, should anything require attention, corrective action and audit trails. Temperature@alert’s solutions are more than just sensors and software; they are reliable and autonomous partners in asset protection and regulation compliance, and there’s nothing sour about that.

    Temperature@lert Food Service Monitoring Guide




    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • Building a GMP Sundae

    Ice cream has long been an emotionally critical component of my diet. During high school, and regardless of the season, I would eat an entire pint of Vermont-sourced, peanut butter cup heaven every Monday afternoon. Mondays were quite often rest days for my sports teams, and there was nothing like both icing a nagging injury and fulfilling an insuppressible craving with a healthy serving of frozen dairy—two needs; one pint.


    peanut butter ice cream picture

    Though my teenage metabolism has since slowed, I still indulge in a now-and-then, waffle-coned scoop of the good stuff during summer months. How can one not succumb to the serendipitous sensory experience that is ice cream? It’s a vehicle for retrospection, rumination, and satisfaction, and, in my opinion, vital to the sustainment of an invigorating life.

    Ice cream plays such an integral and positive role in the lives of people from all backgrounds and locales that it’s difficult to envision not having any due to poor manufacturing or contamination; thus, the duty of maintaining trust between person and product rests with the crystalized confection’s producers. Luckily, for those who carry this heavy yet rewarding burden of crafting and distributing the sweet sacrament, a set of helpful and detailed guidelines exist, the FDA’s Good Manufacturing Practices.

    Initially conceptualized and introduced through the Pure Food and Drug Act of 1904, GMPs were officially formulated by the FDA in the late 1960s and modernized during the mid-to-late 2000s; they encompass the production, storage, and distribution of food, drugs, cosmetics, and other consumer-centric products.

    The portion that deals with human provisions is covered in detail by the Code of Federal Regulations (CFR) 21 Part 110, and some private dairy organizations have produced industry-specific manuals based on the lengthy government document. In general, GMPs cover employee practices, facility conditions, operational controls, and corrective actions, and each subsection highlights the expectations for training, audits, and documentation.

    Free Temperature@lert Ebook

    Employee practices include direction and details on dress, glove use, disease control, and contamination prevention, and facilities should have adequate ventilation and lighting, no pest issues, proper sewer and water systems, and be sanitized regularly. Operational controls are in essence the preventative steps taken to reduce food contamination during production and distribution processes. These steps include the storage and movement of raw materials, equipment sanitization, and environmental monitoring.

    Understanding that human error is often the cause of contamination, the FDA requires that employees be properly educated and trained in GMP, audits of facilities, equipment, and processes be conducted by the agency, and documentation of incidents and corrective actions taken be collected, stored, and made accessible to audit teams.

    With so many microbiological variables and external elements threatening the sanitation and integrity of dairy products, it’s important for all producers of ice cream to operate with vigilance and diligence, employing a system of check and balances that monitors environmental conditions and worker behavior. And because their offering is one that inherently generates happiness and facilitates inter/intrapersonal engagement, creameries have a responsibility to keep one of the world’s few remaining examples of eatable idealism as preserved and untainted as possible.

    Moving forward, this series will look at a few particular points of note from CFR 21 Part 110, connecting each to challenges and incidents within the ice cream world, and share how companies, with the help of technology, are fulfilling their GMP compliance obligations.



    Written by:

    Chris Monaco, Covert Content Creator

    As a man of many achievements, Chris Monaco is Temperature@lert’s newest Covert Content Creator. Hailing from Beverly, MA, Chris is armed with a trifecta of degrees, from a BFA (Maine at Farmington), to an MFA (Lesley University), all the way up to his most recent achievement; the coveted MBA from Suffolk University. Outside of his academic travels, Chris has added many international stamps to his passport, including: Seoul, Korea and Prague, Czech Republic, wherein Chris taught English as a Second Language to dozens of international students. His hobbies include writing, skiing, traveling, reading, and the world of politics. His personal claims to fame include two cross-country car trips through the U.S. and a summer’s worth of courageously guiding whitewater rafting trips. Chris’ ideal temperature is 112°F, the optimal temperature for a crisp shave.

    Chris Monaco Temperature@lert

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  • Why Sweat the Details?


    Complying with mandatory Good Manufacturing Practices (GMPs) can be stressful no matter which vaccine process your biotech, pharmaceutical, or medical company undertakes, but that preoccupation can also be reduced. As previously noted, GMPs are regulated by the FDA and fluctuate between broad and narrow, required and recommended. With the Code of Federal Regulations acting as a compliance manual, firms are expected to validate that their processes and products are safe, effective, and protected.

    Two regulations of particular relevance to vaccines are 21 CFR Part 10.11 and Part 11. First conceived from the National Childhood Vaccine Injury Act (NCVIA) of the late 1980s, Part 10.11 provides requirements for vaccine labeling and breaks down the process review as follows:


         - Proposed labeling must be submitted for pre-approval

         - Package inserts must be included with submission

         - Inserts must have sufficient instructions, warnings, and precautionary information

         - Post-approval surveillance based on medical literature and mortality reports determines whether labeling must be updated


    Added in 1997 and refreshed in 2003, 21 CFR Part 11 specifically deals with the collection and storage of electronic records and signatures:

    The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

    The FDA monitors these electronic entries by requiring that, among other things, the following major components be accessible and accountable:

         - Validation of temperature parameters

         - Auditable data and action logs

         - Record protection


    Failure to provide adequate and consistent electronic documentation may lead to a compliance violation, but such regulatory hassles are avoidable. Technological advances in wireless temperature monitoring have made CFR compliance less intensive than ever. Through device and system automation, you can set temperature boundaries and receive email, SMS, and phone alerts if they are breached. Additionally, all actions and records are time stamped, logged, and stored within a secure cloud service. Your company’s ability to adhere to GMP guidelines will be one less concern in your day, which is what truly matters.

    Like any regulatory standard, the demands of GMPs are numerous, and an infraction costly, but with a proprietary wireless monitoring device and complementary system, you don’t have to sweat the details.

    We’ll continue with pharmaceutical products and their respective CFRs next week.


    Free Guide for Vaccine Monitoring


    Full disclosure: This writer is employed by one such supplier of wireless temperature monitoring systems, Temperature@lert, that help its users to meet complaince.

    Temperature@lert’s ZPoint Cellular Edition ensures that important electronic records (temperature and time logs, alerts, and alert responses) are documented and retained for one year within our Sensor Cloud service. Should the environment you’re monitoring lose power, the ZPoint Cellular Edition’s internal backup battery will keep the device and sensors operational for several days, allowing alerts and measurements to continue without interference. For more information about Temperature@lert’s Cellular and Sensor Cloud offerings, visit our website at http://www.temperaturealert.com/ or call us at +1-866-524-3540.



    Temperature@lert Cellular Edition


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  • Temperature Alert: Notification Sender Change for Sensor Cloud

    SERVICE UPDATE:

    Notification Sender Change for Sensor Cloud Customers

     

    For Temperature@lert customers on sensor cloud, the notification "sender" address will change on May 20, 2013 (Monday).

    • Previously, alerts and notifications were sent from: "support@temperaturealert.com".

    • Going forward, all notifications will be sent from: "notify@myalertlist.com".

    OLD FORMAT:




    This change will take effect in the coming days. Be sure to update your spam folders, address books, and firewalls to prevent bounceback and to ensure prompt delivery of alert notifications. Please contact Temperature@lert with any questions or concerns in regard to this change. 

    NEW FORMAT:


    Please email support@temperaturealert.com if you have any questions!


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  • Temperature@lert Named as Finalist in 2013 American Business Awards

    TEMPERATURE@LERT NAMED AS FINALIST IN 2013 AMERICAN BUSINESS AWARDS


    The 11th annual Stevie® Awards will be presented on June 17 in Chicago and September 16 in San Francisco.

    Boston, MA – May 9, 2013 – Temperature@lert, a leading provider of real-time, cloud-based environmental monitoringsolutions designed to enable businesses to mitigate temperature-related disasters, was named a Finalist today in the New Product or Service of the Year – Software category in The 2013 American Business Awards for their Sensor Cloud service. Temperature@lert will ultimately be a Gold, Silver, or Bronze Stevie® Award winner in the program.

     

    Sensor Cloud is a web-based Software-as-a-Service product for monitoring the environmental conditions of server rooms, bio-pharma vaccine storages, and commercial refrigerators while providing regulatory compliance data logging and alerting for various environmental sensors such as temperature, humidity, water, and more. The fault-tolerant design helps ensure that sensor data is logged and maintained for years, while the website and free iPhone/Android apps enable access to sensor readings and the ability to edit phone calls, emails, and SMS alerts from anywhere.

     

    Temperature@lert’s Cellular Products have previously won several awards, including a Stevie Gold Award for their Solar Cellular Edition in 2012. However, it is Temperature@lert’s Sensor Cloud that serves as the brains of all Cellular Editions with over thousands of devices deployed and running the service. Temperature@lert's WIFI and USB devices can also be connected to Sensor Cloud for a consolidated view of all sensor readings and alert statuses. Temperature@lert’s mission is to create a cost-effective and fault-tolerant system that will allow any user to monitor their assets at any moment, anywhere.

     

    The American Business Awards are the nation’s premier business awards program. All organizations operating in the U.S.A. are eligible to submit nominations – public and private, for-profit and non-profit, large and small. 

     

    The American Business Awards will be presented at two awards events: the ABA's traditional banquet on Monday, June 17 – in Chicago for the first time, after 10 years in New York; and the new product & technology awards event on Monday, September 16 in San Francisco.

     

    More than 3,200 nominations from organizations of all sizes and in virtually every industry were submitted this year for consideration in a wide range of categories, including Most Innovative Company of the Year, Management Team of the Year, Best New Product or Service of the Year, Corporate Social Responsibility Program of the Year, and Executive of the Year, among others.  Temperature@lert is nominated in the New Product or Service of the Year – Software category for their Sensor Cloud service.

     

    “Temperature@lert’s Sensor Cloud service directly addresses every industry’s monitoring needs ranging from server rooms, to farms, to medical storage, and even to commercial food transportation operations. We are deeply honored to be recognized as a finalist for our Sensor Cloud service by the American Business Awards,” said Harry Schechter, CEO/President of Temperature@lert. “This honor only further validates the need for remote temperature monitoringbecause everyone should be able to easily prevent temperature related disasters, regardless of type of industry or size of company. We believe in giving you a solution before you even have a problem.”

     

    Finalists were chosen by more than 140 business professionals nationwide during preliminary judging in April and May.  More than 150 members of nine specialized judging committees will determine Stevie Award placements from among the Finalists during final judging, to take place May 13 - 24.  

     

    Details about The American Business Awards and the list of Finalists in all categories are available at www.StevieAwards.com/ABA.   

     


    About Temperature@lert

    Temperature@lert’s temperature and environmental monitoring solutions provide both real-time and historic views of a location’s temperature and other critical parameters through alerts and cloud-based graphs, data logs and reports. This information allows customers to immediately react to potentially disastrous temperature or other fluctuations in critical environments, as well as provide temperature consistency for regulatory and internal process control requirements. Temperature@lert has more than 40,000 devices installed in over 50 countries around the globe. For more information, please visit www.temperaturealert.com.

     

    About the Stevie Awards

    Stevie Awards are conferred in four programs: The American Business Awards, The International Business Awards, the Stevie Awards for Women in Business, and the Stevie Awards for Sales & Customer Service.  A fifth program, the Asia-Pacific Stevie Awards, will debut this year.  Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide.  Learn more about the Stevie Awards at www.StevieAwards.com.

     

    Sponsors and partners of The 2013 American Business Awards include the Business TalkRadio Network, Callidus Software, Citrix Online, Dynamic Research Corporation, Experian, John Hancock Funds, LifeLock, PetRays, and SoftPro.

     

    ###

     

    Contact:

    Diane Deng

    Temperature@lert

    866-524-3540 x506


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  • Temperature@lert Announces National Natural Products Client Win

    Temperature@lert, a leading provider of high-performance and cost effective temperature monitoring devices, has announced its largest client win in the natural products industry to-date. Temperature@lert’s latest client win illustrates their overall advancement as the premiere choice in temperature monitoring for the natural products industry.

    This is most notable through their latest client win, a well-known leader in the all-natural juices, health beverages, and health food bars market. The client is currently using Temperature@lert’s Cellular Edition and a Sensor Cloud “Pro” Plan for monitoring their products in distribution centers nationwide. By maintaining proper temperature storage conditions, these products will sustain their proper lifespan while also meeting FDA requirements. The client will be alerted to both temperature changes and power failures, and will have access to their data and reports for compliance needs 24/7 through Temperature@lert Sensor Cloud system (via iPhone/Android app or the web interface).

    “In the past year, Temperature@lert has found itself growing at a faster pace in the natural foods and beverages industry, which shows us that it is important to monitor these raw goods at every point in the chain,” stated Temperature@lert CEO/President, Harry Schechter. “It’s very interesting for the whole Temperature@lert team to be able to offer the perfect monitoring solution for any point in any vertical, especially in the natural foods industry, where product storagetemperatures are critical to not just the product but to the health of its users as well.”

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  • Trends in Facilities Management: Embracing Automation

    Facility Management and Emerging Trends

    Sodexo has published their 2013 report on Workplace Trends. In the report, an entire section is dedicated to FacilitiesManagement (FM) and we’ve consolidated their 6 bits of insight into the evolution of FM. Quoting from the report:

    “The survey revealed that:

    1. Facilities are increasingly being recognized as a strategic resource.
       
    2. However, FM has had mixed success achieving strategic alignment with other elements of the business.
       
    3. Large, global organizations face dramatically different challenges than smaller, more local businesses—and they manage their facilities very differently.
       
    4. Financial metrics and cost control continue to dominate FM.
       
    5. Heads of facilities are still buried in day-to-day operation concerns.
       
    6. FM career paths are undergoing significant change, and the FM profession faces a potentially serious future talent shortage.

     

    Going further into #5 on the report, it’s noted that “In spite of the widespread belief that facilities is already strategic, the fact is that the average head of facilities spends over 50% of his/her workday dealing with day-to-day operations issues.”
     

    This is a particularly frustrating statistic. The move to automation technologies and other forms of monitoring is partly fueled by the desire to move Facility Managers out of the smaller, daily tasks, and into the bigger picture as a strategic advisor.  Still, Sodexo notes that, “Despite the challenges, we believe the future for FM is bright, as the profession becomes more critical to organization strategy and effectiveness”.
     

    So what is the solution? We can’t assume that checking equipment, reading data logs, small-scale maintenance, and other tasks are unimportant or irrelevant, but we must divert priorities appropriately. Building and Facility managers should avoid being involved in too many day-to-day activities, such that it may interfere with their role as a strategic advisor. Similar to any business, a CEO “should not” dedicate more than 50% of their time to extraneous issues; they need to stay focused on the strategic development and larger picture (though depending on business size, this may or may not be the case).


    The Bottom Line

    For a Facility manager, this is where the move to automation becomes a relevant time saver, and automation indeed helps to redistribute lower level priorities. To that conclusion, the report notes, “We believe strongly that the pathway to making FM more strategic is to outsource as much of the operational routine work to third-party service providers as possible. Doing so will free up in-house resources that can then spend less time “fire-fighting” and more time planning and thinking long term”.
     

    Going along with the conclusion that a facility manager must take a more significant role in long-term planning and strategy, Temperature@lert is in firm agreement with the benefits of automation, and to that end, we emphasize simplicity in all of our products. Our goal is to remove these simple tasks, and allow managers to dedicate more time to straegy.

    At the core, our products are designed to take the weight off of employees (and Facility managers alike) with regard to temperature and environmental monitoring.  We believe that we’re contributing to the future of facility management, in which tasks like temperature monitoring and control are automated and do not require constant supervision. By ‘outsourcing’ these issues, facility managers can indeed dedicate more time to strategic planning, rather than checking paper logs or relying on other employees to record data. The drawbacks of paper logging are well documented, and is really an example of “working harder, not smarter”. Why maintain old school methods, when the "new school" is more effective, more reliable, and also low-cost?
     

     For instance, our Sensor Cloud web portal is an all-in-one monitoring suite that eliminates the need for excessive paperwork and/or temperature data on-site. Facility managers can easily access reports and graphs when necessary, whereas the advanced alerts are a nice substitute for day-to-day supervision. With simple installation, Temperature@lert devices take the analytics and data out of the priority loop, and into a simple and robust interface that is automatically compiled. Overall, the move to automated systems and operations outsourcing is a growing exponentially, and Temperature@lert is proud to help divert temperature monitoring priorities away from facilities managers and operators.  
     

    To help close the loop, “Among the organizations we interviewed during our research, those that were clearly operating more strategically had outsourced for more of their operational activities than the organizations in which FM was struggling to get resources and recognition”.

    Looking into the crystal ball, what other strategies are you deploying in the near future for effective Facility Management?

     

    For the full Sodexo report, click here


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  • Essential Tech Check List: Building & Retrofitting Your Server Room

    Whether you're building a server room, adding on, or moving equipment there are many considerations to mull over. From the basics to alarm systems, it is important to ensure your server room is efficient and to protect your mission critical equipment. Previously in our blog, we have addressed the issues surrounding the microclimate present in your server room; however, it is critical to have an understanding of how a server room should be laid-out and managed. Use our check list as a guide for promoting security, efficiency, and productivity:

    Our Essential Tech Check List

    (1) Your Basics of Space

    • -Examine the layout of the space and how many units of space you have to work with.

    • -The walls (including ceiling) and doors should isolate the sounds that your equipment is creating.

    • -Check to see which way the door opens. There should also be no windows or other entry points other than the doors in the room.

    • -Consider the floor and whether your equipment will need raised flooring. Aim for anti-static floor finishing to prevent an unwanted static charge.

    • -Make sure there is enough clearance for racks and that they are stable enough to hold your equipment.

    • -Check for aisle clearance too, make sure your have enough room for exhaust to escape and not over-heat nearby equipment.

    • -Think about whether you need ladder racks, cabinets, shelves, patch panels, or rack mounts.

    • -Take into weight and size of each piece of equipment into consideration when designing the layout.


    (2) Keeping Your Cool

    • -Check and see what type if centralized cooling is available, whether an under the floor air distribution or an air duct system.

    • -If there is no centralized system available, get an air conditioner or cooling unit that is able to keep your equipment working productively while minimizing energy consumption and costs.

    • -If at all possible, fresh air vents are great and save on energy costs and consumption!

    • -Remove any and all radiators or other heating equipment currently present in the room. You don't need to add heat at all!

    • -Monitor your cooling system(s) to make sure it is working properly, especially when no one is there.

    • -Make sure your cooling units are not too close in proximity to your electrical equipment, think condensation and flooding. Do not place air conditioning units over your servers.

    • -Monitor the humidity to prevent static charge and electrical shorts.

    • -See if a chilled water system is in the budget or find something within the budget constraints to ensure that the hot air has somewhere to go.

     

    (3) Using Your Power

    • -Check to make sure that you have enough outlets to support power to all your equipment and not to overload them.

    • -Get backup power, preferably UPS to prevent data loss from power blinking or outages.

    • -Don't surpass the maximum electrical intensity per unit of space.

    • -Consider shut down capabilities of equipment (SNMP traps for example).

    • -Make sure your equipment is grounded.

    • -Monitor for power outages if you are not using back-up power systems.

    • -Monitor your back up power systems to make sure your mission critical equipment is not failing due to power loss.

     

    (4) Keeping Secure & Safe

    • -Have at least one phone present in the room in case of emergencies.

    • -Either check for a preexisting fire alarm system and install one if there isn't.

    • -Get a fire suppression system if there is not one there. Take into consideration of whether you will have a wet or dry suppression system and the effects that will have on your equipment. (Halon is a great choice!)

    • -Have reliable contacts to help resolve issues immediately, or form a system of escalation.

    • -Monitor for flooding, especially if this has happened historically in the past.

    • -Secure entrances/exits, this is expensive equipment with critical data, you don't want just anyone in there messing around!

     

    (5) Other Considerations

    • -Get the best cabling/wiring available within budget constraints. 

    • -Keep extra cabling/wiring around, because you never know when you may need it.

    • -Consider color coding wires/cables, a little more work now but definitely a time-saver in the future!

    • -Think about lighting: location & heat produced.

    • -If there is someone sharing the space, get them some earplugs! It's going to be loud in there with the equipment being used.

    • -Consider networking/phone lines being run in there and how much space you have left after that.

    • -Plan for future expansion or retrofitting (again).

    • -Leave the service loops in the ceilings.

    • -Label outlets.

    • -Get rid of dust, your equipment hates it!

    • -Check if you have a rodent/pest problem.

    • -Cover emergency shutoff switches so that it can't be accidentally triggered.

    • -Try to centralize the room in the building so that you can eliminate having to use more cabling/wiring than you need to.

    • -Meet OSHA and ASHRAE guidelines as well local codes.


    Is your server room or do you know of someone's server room that is not being monitored for temperature? Are you concerned with energy consumption, ability to monitor off-hours, and/or preventing mission critical equipment from failure? If you or know someone who is experiencing such issues, we want to hear form YOU!

    We will be giving away ONE FREE USB DEVICE per month to the server room with the most need! Valued at $129.99,Temperature@lert USB Edition is a low-cost, high-performance device that monitors the ambient temperature in your server room and alerts you via email when the temperature rises or falls outside your acceptable range.

    Please send a brief description, pictures, and/or videos to diane@temperaturealert.com for consideration! Our team will select one winner each month based on description and need, because we firmly believe that companies in every industry 


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  • Temperature@lert Surpasses Over $1 Billion in Assets Protected

    Temperature@lert, a leading provider of low-cost, high-performance temperature monitoring products, is now protecting over $1 Billion of customer assets.  Temperature@lert's mission is to provide companies and individuals with remote monitoring and alerting of temperature and other environmental conditions to alleviate customer worries about system malfunctions or product damage due to changes in temperature or other environmental conditions. 

    Temperature@lert was founded and funded in 2005 by CEO Harry Schechter in Washington, D.C. with the USB Edition as their first temperature-monitoring device developed. Currently Temperature@lert’s central office is located in Boston, MA and their current product and service offerings include: USB Edition, WiFi Edition, Cellular Edition, Solar Cellular Edition, and Sensor Cloud. Several of their products and services have won awards ranging from the MITX Innovation Awards to the American Business Awards’ Gold Stevie.

    Temperature@lert’s award-winning devices have aided users in major industries spanning from Information Technology (IT) to Biopharmaceuticals and Medical to Commercial Refrigeration.  Clients include Abbott Laboratories, Microsoft, Apple, Heil Environmental, Merck Corporation, University of Connecticut, Vanderbilt University, and University of Pennsylvania to name a few.

    “By giving 110% personally and having established a talented team willing to do the same, Temperature@lert has successfully grown in both research & development and users over the past eight years,” says CEO & President, Harry Schechter. “We now protect over $1 Billion of customer assets with over 40,000 devices in 50 countries with the world’s easiest to use solution. Temperature@lert’s mission to monitor environmental conditions and prevent problems related to such conditions is truly being realized and fulfilled. We strive to keep innovating and alleviating environmental conditions related disasters globally.”

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  • Can BioPharma Quality Assurance Specialists Do It All?

    When we imagine the biopharma industry as a whole, we tend to hover over the same key phrases: innovation, growth, discovery, etc. But in fact, with a few exceptions, the biopharma industry growth has gone sluggish in many states, and has grown in very few. 

    Citing recent data from the U.S. Bureau of Labor and a well-designed report from the Massachusetts Biotechnology Council(MassBio), of the 15 “leading” biopharma manufacturing states, only 5 states have increased employment. As a whole,industry employment has declined by 7.9% since 2002Though these numbers are concerning, Massachusetts seems to be one extraordinary exception to the rule. By state, Massachusetts is twice as dense (as other states) in terms of biotechnology research, development, and employment. Ironically, Massachusetts was the source of the recent Meningitis outbreak. 

    But this hasn't been the only mistake/outbreak of 2012. We can do a news search for past events, but more importantly, where is the proof that lessons have been learned? How can we tell if the mistakes of 2012 will happen again? At a high level, looking at data from the last 3 years, we're headed in the right direction in terms of hiring. 

    Diving deeper, is there evidence that biopharma and biotech companies are proactive?  Is quality control and best practices in vaccine storage a pressing concern of theirs, and what have they done to address it? 

     

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    The answer, in short statistical form, is yes. The institution of best practices and safety guidelines is a hot button issue for the biotechnology and biopharma industry. In fact, “Quality Assurance” and “Quality Control” job listings have been on asteady rise since 2008. Job listings from MassBio.org show over an 80% increase for these specialized positions since then. Other positions have increased by up to 30%, but in contrast to quality assurance and control; we can see clear-cut dedication. The employment spike shows a true and proactive HR response to the rising concerns of vaccine storage and handling

    Still members of the biopharma industry must follow all best practice guidelines outlined by the CDC, and the push to hire “quality assurance specialists” is not a complete solution to the problem. Science fiction movies often illustrate the extreme horrors of vaccine mishandling and disease outbreaks that are caused by human error and/or relaxed security procedures. Despite the extremity of situational presentation in these films there really is an unspoken truth behind them. We cannot solely rely on capable employees. The rise in hiring for quality assurance and control positions is a promising sign, but there must be adequate technology to supplement the increase in manpower. Temperature monitoring is a good example, since employees must ensure that specific vaccines are stored at preset temperatures. However, truth is, no matter how many employees a company has, small changes in temperature must be monitored by certified and accurate technologies.  

    What we can learn from these various statistics is that proactive deterrence (a theme we’ve been tossing around quite a bit in other industries), is a multi-faceted animal. While individual states may show evidence of “employment growth” and perhaps an uptick in manpower related to quality assurance; vaccines and medicine require more than just a brain and body.

    Temperature monitors are ‘by-the-book’ devices that need to be used alongside competent employees. And in truth, all biotech and biopharma companies should have fault tolerant monitoring technology and quality assurance hardware. Institution of simple technologies such as buffer vials (for temperature sensors), will help decrease confusion and increase measurement accuracy for sensitive applications. The buffers provide a 'shield' around the sensor, preventing momentary temperature changes from an opened refrigerator door that can skew data or trigger false temperature alerts.

    New employees will appreciate the availability of helpful (and simple) technology, which is important to establish safe handling practices that have become standardized and remain consistent within the various industries. Hopefully, the investment has gone both ways, and this recent rise in specialized positions is piggy-backed by a push for 'battle-hardened' temperature monitoring systems. In preparation for 2013, we want to direct you towards a list of guidelines that must be followed as per the CDC for vaccine storage and handling. As the CDC shows, responsible quality assurance employees and reliable monitoring technology truly go hand-in-vial.

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