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OCEASOFT Inc., is pleased to announce a new collaboration with AVOGADRO LS

July 02, 2018
Pharma
New collaboration with AVOGADRO LS

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.

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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
Food Cold Chain Management - Temperature data logger | OCEASOFT
Food

Changes within the food industry are rampant, spurred on by movements to deliver goods even faster to consumers while accommodating even stricter regulations by agencies like the U.S. Food and Drug Administration (FDA). For many companies, these shifts are introducing additional challenges in food cold chain management.

 

Here are the five biggest food cold chain challenges to hit the market:

 

1. How you choose a carrier

One of the most significant hurdles in cold chain management for the food sector is carrier selection. While many businesses focus on the cost of their choice, they learn in a short amount of time that low-cost carriers often cost more by mismanaging products, causing spoilage and in some cases, incurring fines from overseeing agencies. That’s why it’s vital to choose a dedicated carrier that meets all your criteria and provides the following:

  • On-time service
  • Reliable transportation equipment
  • Compliant protocols
  • Knowledgeable drivers and dispatchers

It’s also recommended to evaluate your courier on a continual basis. Over time, many can become lax and decrease their level of service, which risks your product and consumer safety. While you can assess your carrier yourself, you can also entrust a third-party logistics (3PL) firm with the task. If you’re unfamiliar with carrier selection, 3PL firms are a sound investment. They’ll compare carriers in your area, as well as their capabilities, plus negotiate their rates for you, which ensures your company receives a competitive price from a trusted shipper.

 

2. How you manage cold chain information

Food Cold Chain management | OCEASOFTData is a critical part of food cold chain management, yet 75 percent of food waste occurs during production and distribution, indicating a substantial gap in communication and supervision by the parties involved. That’s why federal agencies, such as the FDA, are demanding the extensive collection and analysis of electronic records.

In addition to the requests outlined in Part 11 of Title 21 of the Code of Federal Regulations (CFR) — better known as 21 CFR Part 11 — it’s recommended that suppliers in the food industry inspect the facilities of their distributors and wholesalers to ensure they’re producing the necessary information for cold chain records.

During your inspections, review the following factors:

  • Sanitation
  • Pest control
  • Standard operating procedures (SOPs)
  • Temperature
  • Security

While some features, such as temperature histories and SOPs, should be available via digital records, others are only accessible through visiting the facility. Third-party firms can conduct these audits on your behalf and check for evidence of information mismanagement, such as the absence of audit trails or modification of records.

 

3. How you meet cold chain regulations

A continuous challenge of the food cold chain is complying with regulations. Each year, domestic and foreign agencies develop new standards that companies must meet if they wish to continue offering their products to consumers and avoid substantial fines.

The Food Safety Modernization Act (FSMA) poses a significant hurdle too, as it places the responsibility of compliance with the supplier, versus the carrier — unless the contract between the two parties specifies otherwise. Thus, if your carrier violates an FSMA standard, your company is liable.

As a way to counter stricter regulations for food cold chain management, companies are incorporating the standards of agencies into their SOPs, thus requiring every member of their supply chain to adhere to them. Businesses are also certifying their facilities and partnering with accredited couriers, distributors and wholesalers.

Read our article to understand how the food safety modernization act (FSMA) is changing standards in temperature-controlled shipping.

 

4. How you monitor products in the cold chain

One of the food cold chain challenges that have plagued the food industry for years is monitoring goods. Due to existing technology, it was cost-prohibitive and ineffective to follow a shipment on its journey through your supply chain. The downside of not doing so was an inability to see where and when a product became spoiled.

With wireless technology, however, notably the Internet of Things, it’s now feasible for companies to track the condition of their products from beginning to end. Bluetooth temperature data loggers, for example, are often sent with shipments as they provide real-time status updates to you and your courier’s drivers.

Technology has also entered cold chain food storage facilities. Newer temperature-controlled warehouses, for instance, feature self-contained refrigeration units that offer increased energy efficiency and zero water requirements, plus convenient monitoring systems that use wireless data loggers.

Watch our webinar and learn how the IoT is shaking up cold chain management.

 

5. How you deliver goods

Amazon’s entry into the food sector signals a shift in how consumers receive their groceries — it also represents a new challenge in food cold chain management. Companies are now preparing for the growing preference of shoppers to buy direct, as well as opt into curbside pick-up, home delivery and more.

These changes lead to new hurdles that challenge the industry to innovate the cold chain even further. Examples of new challenges include ensuring customers pick up or receive their food within an appropriate window for maximum freshness, as well as optimizing routes and expanding distribution locations to access more consumers.

While solutions to this movement are underway, it’s inevitable that the market will need to enhance their infrastructure and streamline their food cold chain management to deliver food that’s safe, fresh and compliant with domestic and international agencies.

 

Counter food cold chain challenges with OCEASOFT

At OCEASOFT, we bring more than 15 years of experience to the table. Our ISO-certified company, which specializes in delivering innovative solutions for a safer world, develops compliant wireless products for temperature monitoring and more, providing your business with essential information in real-time.

Explore our product line-up to learn more about our innovative and compliant solutions.

04 April 2018
FSMA - Food Safety Modernization Act - Logo | OCEASOFT
Food, Logistics, Regulation

After several years of development following its passage in 2011, the Food Safety Modernization Act (FSMA) is now in effect. As the legislation transitions the U.S. Food and Drug Administration (FDA) into a law enforcement authority, versus regulatory agency, it’s critical for shippers and couriers within the food industry to understand its impact on temperature-controlled transportation.

 

FSMA - Food Safety Modernization Act - Logo | OCEASOFT

Carry Responsibility for Food Safety

One of the most significant changes ushered in by FSMA is how it delegates the responsibility of food safety. Instead of placing accountability with the individual or organization in possession of a shipment, such as a courier or a distributor, the burden is almost always with the producer or shipper.

Exceptions to this food safety transportation standard are contractual agreements. You may, for example, sign a contract with your courier that states they are responsible and liable for the safety of your food items during transportation. It’s essential to note that accountability can shift back to you. If your contract, for instance, assigns compliance responsibilities to a party not covered by FSMA — thus, anyone other than shippers, receivers, loaders and carriers — your company is liable for their non-compliance.

 

Develop a Temperature Monitoring Mechanism

In 2011, FSMA required companies to use temperature indicating or temperature recording devices during transportation. That changed, however, and the FDA now mandates that shippers and carriers implement a temperature monitoring mechanism. This requirement is perhaps one of the most critical factors in food safety transportation, as it ensures parties keep products at an optimal temperature for freshness, flavor and texture — which avoids the potential financial losses and brand damage of spoiled food entering the marketplace.

As a part of your temperature monitoring mechanism, your carrier must maintain a record of temperatures. The reason for this requirement is that FSMA mandates that couriers produce documents upon request from either you or the FDA. The most trusted method for fulfilling this food safety transportation standard is via data loggers.

 

Create Sanitary Procedures

Per FSMA, food transportation must follow the shipper’s established sanitary procedures. For every product your company produces, you will need to develop a set of sanitary protocols, which can detail how to load, store and transport your goods, as well as clean the transporting vehicle.

Controlled-temperature transportation solutions | OCEASOFTProvide your instructions in a physical format to your courier — and loaders if the procedures apply to them. If your sanitary requirements change over time, ensure your team revises the existing standards and provides them to your courier and loaders before the next shipment.

If your carrier deviates from your sanitary protocols, it’s vital your company acts, as you’re liable for their non-compliance with food safety transportation standards. Potential actions you can take include modifying your instructions to be more concise, as well as terminating your contract.

 

Implement a Food Safety Training Program

With FSMA’s passage, it’s critical to review your existing carriers. FSMA requires carrier personnel to undergo food safety training, which ensures drivers, loaders and other staff possess the necessary knowledge and experience to handle temperature-sensitive goods.

The FDA asks that drivers, in particular, undergo a one-hour course before starting. While the FDA is in the process of collaborating with trusted organizations to develop a set of certified classes, there are none available now to accommodate the FSMA’s food transportation standards.

It’s recommended, however, that your couriers direct their drivers and staff to similar courses. This act demonstrates to the FDA that your company and its partners are committed to educating their staff about food safety practices.

 

Establish Recordkeeping Protocols

As Title 21, Part 11 of the Code of Federal Regulations (CFR) emphasizes, recordkeeping is significant to the FDA. As a result, FSMA mandates extensive recordkeeping by shippers and carriers. The specific focus of documentation in food safety transportation is temperature.

Carriers must provide temperature documentation on request, as well as maintain records regarding vehicle maintenance and performance, fleet movements and routes. Documents like these can often serve as evidence that your drivers understand and comply with FSMA’s food transportation requirements.

 

Define Preventative and Reactive Controls

Via FSMA, the FDA asks companies to be proactive and reactive. That’s why your business, as a producer and shipper, must establish a food safety plan and risk-based preventative controls, as well as evaluate hazards in your facility and supply chain.

As a part of your hazard analysis, you should identify how your company will manage these risks and counter them if they become an active hazard. You may also implement some corrective actions to alleviate specific hazards. Separate from your hazard analysis, your team should also develop a plan for recalling products.

It’s essential to note that per these new food safety transportation standards, the FDA can now recall food items without your company’s permission. They may only use this power after notifying a producer about the risk of their product and after the producer does not take action.

 

Meet Food Safety Transportation Standards With OCEASOFT

At OCEASOFT, we develop innovative solutions for a safer world. With more than 15 years of experience, as well as a unique understanding of the regulations surrounding the pharmaceutical, healthcare and food industry, we’ve established ourselves as a trusted and ISO-certified provider of monitoring solutions for a range of applications.

Explore our solutions today and discover how they support food safety transportation standards.

04 March 2018
Cloud Data Storage - OCEASOFT
Tips
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
25 January 2018