Monitor, track and react to real-time asset data and resources from anywhere around the globe.
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blueRover technology is able to track, trace and monitor food product temperatures in real-time. We can help your business validate […]
Research Entrepreneurs Accelerating Program (REAP), in conjunction with Felt Labs, is now displaying blueRover mobile technology. blueRover technology provides a […]
Take the Hazards out of HACCP
The transportation, food, cosmetic and pharmaceuticals industries must comply with hazard analysis critical control point (HACCP) principles for production and preparation processes.
Use blueRover to help you monitor, verify and validate your processes for compliance with regulatory requirements.
Cold chain logistics is a core element of the pharmaceutical supply chain, keeping products at a consistent temperature from the point of manufacture to their final destination. Most cold chain products are licensed to be stored between temperatures of +2°C and +8°C. However, temperature controlled supply chains are not always ‘cool’. Some products need be kept frozen – this is often achieved by packing it with dry ice. Other products must be kept warm – usually this means a room temperature range of +15 to +25°C.
A broken cold chain can cost not only many vulnerable lives, but can cost a business millions as a result of temperature deviations within the chain. It is estimated that an average of 25% of all healthcare products are temperature-sensitive, and require refrigeration during transportation and storage. Temperature monitoring and maintaining the right packaging environment during transport are elemental to maintaining the viability of these high-value shipments.
Let blueRover be the champion of your bespoke and routine cold chain shipments. blueRover’s advanced technology can take your organization to the forefront of health and safety, minimizing risks to the patient and the consequences of risks to your organization:
Broad spectrum monitoring.
blueRover facilitates on-site and remote tracking of variables such as temperature and humidity levels. A journey history of the temperature and humidity levels experienced can provide the deciding information for product release.
With blueRover, you can secure inventory checkpoints in 'real-time', at each step of the drug production and transportation process.
blueRover protects your assets from product theft and tampering.
With blueRover, you can ensure your compliance with GMP, GCP (good clinical practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) guidelines.
Good Manufacturing Practice
Good manufacturing practice (GMP) comprises all the procedures and practices that are required to ensure the quality of a product. Increasingly, countries are legislating that pharmaceutical and medical device companies must follow GMP procedures, and many companies have established their own GMP guidelines that meet legislative requirements; safeguarding the health of the patient as well as producing high quality medicines or medical devices. In the US, a drug may be declared adulterated if it has passed all of the specifications tests, but is found to be manufactured in an environment that violates current good manufacturing guidelines.
On-site and remote tracking of critical control points.
blueRover can help you validate all your critical processes to ensure consistency and compliance with specifications.
Ease of use.
blueRover is user-friendly, and can be installed into any existing monitoring system.
Advanced communications ability.
Documentation is critical. blueRover provides detailed audit reports to support regulatory requirements for product safety.
Cold chains are subject to ever-increasing compliance requirements. All processes that might impact the safety, efficacy or quality of the drug substance must be validated as required by various regulatory bodies such as the FDA and the DOT Department of Transportation); these include the storage, handling and distribution of the drug substance. With blueRover, you can show in real-time that the product has been delivered under the right conditions throughout the cold chain, including dock-time. blueRover’s technology allows the configuration of control mechanisms to respond to adverse conditions such as a power failure or unforeseen delays.
blueRover training is provided for all personnel involved in the cold chain distribution process, and covers product handling and preventative and reactive responses to a range of environmental conditions, supported by comprehensive, written, safety plans.