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Top 3 benefits of real-time monitoring and Cloud data storage

January 25, 2018
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Atlas: Bluetooth single use data logger with Cloud data storage - OCEASOFT
GxP regulated companies in life science and agro-food alike have specific needs surrounding data integrity, storage and compliance. Companies may use various methods for logging and storing data ; anywhere from hand-written and signed paper trails to single computer data storage to multi-server data centers. These tedious methods of data storage can quickly lead to errors, non compliant work-flow, security breaches, and loss of data due to computer or server crashes, all of which can ultimately compromise patient safety and impact regulatory status of the company.
 
OCEASOFT has developed various monitoring solutions that can not only store data on a company’s physical server, but will store data in Amazon Web Services’ (AWS) GxP compliant cloud (our cloud service, OCEACloud) that meets regulators needs by ensuring the integrity, reproduceability and traceability of data used when manufacturing, storing, and shipping clinical or commercial products. 
 
Pharmaceutical, biotechnology, vaccine, medical device, food and other regulated companies should consider implementing or upgrading to OCEASOFTmonitoring with cloud storage for a number of reasons. 
  1. Storing data on OCEACloud replaces up front expenses and resources such as planning for, purchasing, installing servers and manually validating the system.
  2. Data in the physical realm is only available and accessed on the company network. With OCEACloud, users to login with unique credentials to access data from anywhere in the world on their smartphone or tablet by downloading our free mobile apps from the iTunes App Store, or Google Play.
  3. Due to infinite scalability, companies can grow data storage as business needs expand; aggregate data from research and development, manufacturing, storage and shipping sites, into one cloud network.

 

The advantages of Cloud data storage for temperature monitoring

A perfect example when OCEACloud storage is essential, is when companies who conduct clinical trials ship their temperature-sensitive products globally. Instead of waiting for the clinical trial site or end-user to download data, e-mail files, or physically mail the logger back.
Quality, Regulatory and Clinical Trial Managers can instantly view data and receive alerts from their personal work station or smartphone to determine if an excursion occured, and if the drug is safe to administer to patient. In cases such as this, real-time data becomes imperative. By using our cloud-enabled devices, such as our Atlas disposable temperature data logger, customers can make data-driven decisions, and potentially save thousands of dollars from product loss, while still meeting regulatory and GxP standards.
 
 
The Cloud also helps aggregate data gathered by both mobile (like Cobalt ML3) and stationary (like Cobalt L3) monitoring solutions. (Watch our webinar to learn more).
 
Temperature monitoring with Atlas single use data logger and data storage on the Cloud
 
Learn more about OCEACloud, and how we can help your company maintain compliance, profitability, and meet real-time monitoring needs
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As communicated previously, Oceasoft and Dickson merged in December 2019. Over the past two years we have been working behind the scenes to combine our resources and position ourselves to be the best environmental monitoring partners to you, our customers.

 

Beginning January 2022, our combined company will go to market under one global identity: Dickson.  Starting this month you will begin seeing name updates to our email addresses, materials, hardware, and website as we begin unifying under the Dickson brand. Our unified brand represents the synergy of our merger and the ways in which we expect to continue developing our products, support, worldwide footprint and overall service to you.

 

In the enclosed infographic, we describe facts and benefits that derive from the combination of our two expert companies.

 

 

A few key  points:

●      France will remain the hub of our European sales, support, operations, calibration, and engineering development; in fact we are aggressively adding new talent and capabilities here

●      The highly regarded OCEAView, Cobalt, Atlas and Emerald brands--as well as their supporting services and teams--will remain front-and-center

●      We’re making significant investments to cement our position as “best software platform” with supporting sensors, instruments and services for all health, pharmaceutical, medical, food and other regulated industries’ environmental monitoring requirements.

 

We see this alignment under a single company banner as timely and appropriate as we continue to integrate teams, products and services worldwide. Please reach out with any comments or questions you may have. Thank you for your continued business.

 

Best regards,
 

Laurent Rousseau

Managing Director

 

05 January 2022
data loggers in gene therapy
Healthcare

Gene therapy is quickly becoming one of the most talked-about advances in medical science. With the immediate ability to treat a handful of extremely difficult diseases — retinal dystrophy, a form of lymphoma and a type of leukemia, as of now — it is a treatment that shows promise in tackling a large number of other diseases that have resisted treatment. These include other rare diseases, cancers, HIV, Parkinson's Disease, hemophilia and severe combined immunodeficiencies. The treatments have recently qualified for fast-track approval with the FDA, meaning they may be able to reach the market sooner than other drugs.

 

Monitoring of manufacturing, storage and transportation conditions in real time, is an invaluable asset. Data loggers provide trackable data for factors like temperature, humidity, differential pressure , CO2, and particle size for clean room operations, , Data loggers like the Oceasoft Cobalt 2 offer an extremely cost-effective solution in terms of both protection and compliance.

 

We will examine how the Cobalt 2 offers the opportunity to save millions of dollars, protect patients' lives and help meet compliance checks.

 

replacement gene therapy

 

What Is the Cobalt 2?

Cobalt 2 is one of Oceasoft's premier data loggers. With it, users can achieve continuous monitoring in real time for the following factors:

  • Temperature
  • Humidity
  • Differential pressure
  • CO2 content
  • Particle Size with integration of 3rd party devices

 

This versatility is achieved through Cobalt 2's many sensors. By giving you state-of-the-art, comprehensive monitoring, you can also stay ahead of compliance requirements for GxP and GMP, in a 21 CFR Part 11 environment.

 

One of Cobalt 2's greatest assets is its simplicity and intuitive interface. This means reliable monitoring of your equipment and processes without added time or effort trying to understand the device. If something goes wrong, Cobalt 2 sends real-time alerts via voice calls, SMS/text messaging or email. This means peace of mind for companies for whom small equipment failures can have catastrophic consequences.

 

Cobalt 2

 

The data end of the Cobalt 2 makes it doubly useful. First, Cobalt 2 uses industry-leading security protocols to keep data safe and secure while interfacing with other information systems. Secondly, its creators prioritized accessibility in the layout of its design. That means a format where searches for data are quick and simple — not frustrating or laborious. Finally, the data produced is auditable. If needed for audits or compliance checks, the data can be provided to the other party in a readily interpreted format.

 

There are over 160,000 data loggers in use across the globe. With the Cobalt 2, you will be getting compliance, a small device profile with a high-visibility LCD screen, exceptional wireless connectivity, unlimited reading storage, different options for units and much more.

 

Cobalt 2 and Compliance

There are obvious advantages to having an FDA- and GMP-compliant data logger. Most gene therapy companies are operating in the stages where the drugs in use are still not FDA-approved, or are in an investigational program. For this reason, they may not require compliance just yet. However, following GxP compliance during this stage of the process is still wise, as approval could mean being audited and needing to prove compliance retroactively. Being able to hand over data that proves compliance during the entire operation can greatly expedite the approval process.

 

A key benefit of using a Cobalt 2 for data logging in the gene and cell therapy applications is its ability to save companies significant amounts of money during the auditing process. The Cobalt 2 is made not only for reliable monitoring but also to aid in all types of auditing by showing traceability in the system. One key to success during this process is being able to present a comprehensive dataset with all of the needed parameters.

 

data logging in the gene therapy industry

 

The other key to success in the event of an unexpected audit is being able to provide an audit trail. This document differs from simply showing the auditor a database. In it, the auditor can find traceability of every action taken within the software. Cobalt 2 makes this process simple. For example, if it is being used as a temperature monitor on a product storage freezer and the parameters are set to –80ºC, the audit trail records the parameter at the start date and time.

 

Save Millions of Dollars and Protect Patient Safety

The cell and gene therapies that are currently in development represent millions of dollars of research and investment that are vulnerable to electrical and mechanical systems failing. The Cobalt 2's real-time alerting features provide insurance against the possibility of catastrophic failures compromising developments.

 

An example of such a situation is a storage freezer that houses a product. If someone improperly closes the freezer door and the temperature rises too high, this can completely destroy a product the company has been working on for months or years, easily costing half a million dollars. Electrical issues or worn-out parts can also cause such problems. The Cobalt 2 would notify an on-site employee about the temperature increase so the product could be relocated. This helps protect against product loss in terms of money and time spent on research and development, including both researching the gene therapy and the money on raw materials.

 

Patient safety is another key issue for cell and gene therapy companies. If the temperature of a product deviates too far from spec, this can have dangerous or lethal consequences for the patient. Gene therapies rely on precise specifications — temperature in a freezer or humidity in a clean room, for example — and if they deviate, the structure of the cell can change and the result can be lethal. Cobalt 2 protects patients' lives and ensures that a dip in temperature never goes unnoticed.

 

Protecting Investments

Protecting the investments put into gene therapies go beyond the facilities in which they are made. Shipping the products out to hospitals and clinics involves packing them in a small vial within a large tank. This setup alone can cost $100,000. The tank is cooled by liquid nitrogen, and if the nitrogen is low and isn't freezing at the point it should be, the product within can undergo changes. That would mean the company loses a huge amount of money on a single dose for one patient.

 

Crossing this threshold is a critical step. If a reliable data logger has been in use throughout the manufacturing process, the company can make the transition easily. Cobalt 2's environmental monitoring and audit-friendly software can make this part of the process go smoothly. A company that has performed continuous monitoring throughout the process can simply hand over the needed materials and then move forward. Essentially, this makes a very simple process out of a potentially complicated one, saving lots of money.

 

Versatility in a Fast-Paced Industry

Cell and gene therapies constitute one of the fastest-moving industries in medicine. Companies are moving quickly because, as of now, there are practically no gene therapies on the market. In these companies, a great deal of money has been invested in the hopes of becoming one of the top 10 companies providing approved gene therapies — every company is racing to be next.

 

gene therapy

 

One of the side effects of this race is that there is not a lot of time to design and build state-of-the-art facilities. Instead, the new standard is to have clean room companies install pods that can be moved around a facility as technologies develop. This is different from traditional manufacturing, where a company has its dedicated facility and has used it for several decades.

 

The rise of clean room pods has led to a sort of modular set — the company builds pods and moves them around to meet the manufacturing needs for that particular year. This saves them millions of dollars that they would have had to spend in putting together a full-fledged facility. The Cobalt 2 has this type of modular spirit built into it.

 

Some data logger systems are hard-wired into facilities. This means data loggers involve running wires through walls and ceilings with hundreds of feet of cabling that is expensive and a hassle to install. Installers must know exactly where every sensor is and install the corresponding cables through the system.

 

The Cobalt 2, by comparison, is the size of a small walkie-talkie and is both wireless and modular. It comes with five different optional sensors and installing it is as easy as sticking it inside a refrigerator or freezer. If you need to move it, you can — because it is not wired, there is no need to worry about cabling. You can also expand and add on different data loggers as the business changes or expands. You do not need to know the entire layout before you start.

 

Learn More About the Capabilities of Cobalt 2

If you are interested in learning more about Cobalt 2's ability to save money and protect patient safety, contact Oceasoft with questions.

 

View the Colbalt 2

18 July 2018
New collaboration with AVOGADRO LS
Pharma

OCEASOFT Inc. is pleased to announce a new collaboration with AVOGADRO LS, a Contract Research Organization, located in Fontenilles (France) and Terre Haute, IN (USA), providing expertise in various areas including metabolism, pharmacokinetic, safety and efficacy studies for human and veterinary drug development. AVOGADRO LS has partnered with OCEASOFT SA, in France and USA to integrate on both sites the OCEASOFT wireless monitoring solution.

 

AVOGADRO LS’s challenge was to implement a fully validated and compliant monitoring solution for their critical equipment such as -80°C and -20°C freezers. The solution needed to provide real time data, as well as alerts to the facility staff. Additionally, AVOGADRO LS had a requirement for a solution that to generate customized reports, access to an audit trail of all events and data associated with their facilities and equipment.

 

OCEASOFT deployed its Cobalt 2 system which meets all the requirements described above. The system is 21 CFR Part 11 compliant and is easily expandable to monitor other environmental parameters such as humidity, differential pressure, CO2 and much more.

02 July 2018
Strategic partnership for blockchain-integrated temperature monitoring solution | Chronicled | OCEASOFT
Research

Chronicled, Inc. a smart supply chain solutions company based in San Francisco, CA, and OCEASOFT announced a strategic partnership to cross-sell and integrate each other's platforms and solutions.

 

Chronicled-OCEASOFT partnership for Blockchain-integrated cold chain monitoring solution"By partnering with Chronicled, we gain a solid blockchain strategy. As the pharmaceutical industry in the United States moves onto blockchain to meet its track-and-trace requirements, we can leverage our partnership to integrate these workflows and cold chain monitoring requirements to provide more value and better ROI for customers," says Laurent Rousseau, CEO of OCEASOFT.

 

"We've discussed cold chain monitoring objectives with many of our life sciences customers," says Ryan Orr, CEO of Chronicled.  "Our goal is to make best-in-class technologies available on our platform to meet industry requirements. With wireless connectivity, OCEASOFT temperature data loggers solve many of the problems faced in the cold chain logistics industry, notably eliminating the need for USB plugs; automating data retrieval with BLE, LoRaWAN, and 5G gateways; and offering cross-site visibility of information via apps and a Cloud-based dashboard."

 

When blockchain meets cold chain

When blockchain and cold chain come together, added value can be achieved with respect to conventional systems, including:

 

Secure Data Logs for Audit - a decentralized blockchain offers improved security and resiliency properties for record-keeping over a central back-end database.
Workflow Integration – workflows for track-and-trace and temperature logging operations can be synchronized, thus reducing duplicate record-keeping and systems.
Automated Financial Transaction – when a temperature excursion occurs, a smart contract can generate an automated payment to redress impacted parties.

About Chronicled
Based in San Francisco, Chronicled is a technology company leveraging blockchain and IoT to bring trust, efficiency, and automation to global supply chain ecosystems. The company is a pioneer in linking physical world economy workflows to blockchain systems and has developed a decentralized protocol and network for supply chain in order to extend trust boundaries and enforce cross-organization business rules without revealing private data. Currently, Chronicled's most active market verticals are Pharmaceuticals, Commodities, and Precious Metals and Minerals.   

See: https://www.chronicled.com

20 June 2018