Digital supply chain solutions for visibility, quality, and compliance.
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As supply chain demand increases and new technologies enter new markets, it is time to evaluate and challenge current temperature monitoring devices and processes. Savvy manufacturers and suppliers understand the need to identify a digital solution that can help them operate with more agility, and improve lean operations, efficiency, productivity, performance, and customer service orientation.
Moreover, as track and trace regulations go into effect — the EU’s Directive Against Falsified Medicines and the US’s Drug Supply Chain Security Act — traceability, security, counterfeit and cargo theft prevention are top of mind for pharmaceutical manufacturers. They must maintain full chain of custody and control over their products as they move through the supply chain. End-to-end cold chain visibility and traceability technology are now mission-critical.
Although pharmaceutical manufacturers and logistics partners provide reliable and stable services, inefficiencies may exist:
Digitalization, smart sensors, connected technology, and services can now enable businesses to:
Leading factors for switching to a real-time visibility solution typically include cost savings, temperature control, patient safety, increased compliance, efficiency, agility, and sustainability. With the right technology and services, enterprises gain an automated solution for packaging and lane validation, risk assessment, operational qualification, product integrity, and supply chain efficiency.
Life sciences and logistics companies should consider several key factors when looking to deploy a real-time visibility solution for their temperature-controlled supply chain.
Reliance on manually retrieved cold chain data at the end of a shipment slows the shipment and review process and can lead to downstream stock outages in critical markets. Today, a cloud-enabled software dashboard can provide Pharma enterprises, shippers, and freight forwarders a single source of truth over the entire supply chain in real-time. This proactive visibility eliminates friction by alerting stakeholders of a temperature deviation. Shipment review can begin immediately and well in advance of receipt of products, which allows for the implementation of corrective action to prevent an excursion. IoT data loggers can remain with products as they travel throughout the supply chain, providing critical supply chain information to all relevant stakeholders.
Today’s IoT monitoring devices support the storage, retrieval, and sharing of time-sensitive and routine shipment information continuously through the cloud. In real-time they can collect time, temperature, location, light events, and tampering information. The devices can immediately transmit sensitive and alert information including shipment duration. At regular intervals routine information is collected. Data collection via the IoT loggers can be manually or automatically started and stopped. Visual alerts automatically display on the device and in the cloud software platform, and notify designated stakeholders of issues requiring escalated attention.
Through sensors and geofencing, technology now automatically captures time, temperature, location data, and light events in real-time, sending critical quality and compliance data to a centralized software platform that is accessible on-demand. A single solution can travel with products from manufacture through last-mile delivery, providing end-to-end visibility, for greater quality and control. Custom, pre-configured shipment templates, alarm boundaries and settings accurately measure reporting on temperatures of products, lanes, packaging, and other variables. Data is available earlier in the shipment process, making it possible to manage by exception and segment problem shipments only for further investigation and review. Root case suggestions facilitate the shipment review process, substantially reducing operational costs.
Security and data privacy requirements are paramount for Pharma IT teams. Data storage, backup, and retrieval must be maintained in a secure data center or system. A cloud-enabled system must be validated and compliant for Pharma applications according to regulation.
Global logistics teams often maintain limited visibility during transportation, as shipment data is often available retrospectively after shipment and after manual efforts, which can yield inconsistent data. Historically, improvements are driven by Corrective and Preventive Actions (CAPA’s) after an issue has arisen. Temperature deviations are often discovered late, and not proactively detected, which can lead to shipment and quality release delays, and other discrepancies where investigation/root cause analysis takes several days and late initiation of a CAPA occurs. A lack of supply chain visibility makes quality management and supplier qualification difficult as well as ensuring that effective remediation actions are implemented in a timely manner, if at all. Today, technology can deliver real-time alerts if a deviation occurs, release notifications, and complete and accurate release reports, triggered immediately at the end of a shipment.
Relevant, timely data and analytics are paramount for supply chain optimization and efficiency. Today’s real-time technology allows for the centralized data collection, shareable with relevant stakeholders. Seamless integration with other business systems including ERP systems such as SAP, is possible through REST API’s. Data can be exported in PDF and Excel format, and custom reporting provides data analytics and insights on supply chain performance, including excursions and saved product loads, lanes and packaging, points of interest, root cause suggestions, and total cost savings.
Traditionally, temperature data loggers were purchased up front. For a Pharma enterprise, this would translate to tens of thousands of data loggers annually, a cumbersome CAPEX cost. Today, real-time cold chain solutions are offered as a cost-effective alternative and provide a single source of truth. IoT hardware, software, and services are included as an all-in-one, leased solution. This provides economy at scale; the solution can be used for all shipments, both high-value products, as well as smaller and less valuable goods. IoT loggers and reverse logistics are managed as an included service, and 24/7 monitoring and response services provide around the clock, control tower visibility, eliminating the need to hire internal resources to manage reusable data loggers and respond to real-time alerts.
Sustainability and environmental concerns are top concerns in today’s supply chain. Preventing replacement shipments, exploring new shipment methods, such as sea freight and LCLs (Less than Container Load), and implementing systems that provide real-time visibility and the ability to proactively protect product quality and integrity will enable enterprises to reduce waste and decrease their carbon footprint.
Today’s efficient temperature-controlled supply chains are partner- and services-focused. Pharma enterprises no longer need simply temperature monitoring data loggers. Rather, a partnership model that includes IoT hardware, access to real-time shipment data via a software dashboard, and a variety of services that automate, streamline, and operationalize the supply chain will increase efficiency, flexibility, and agility going forward.
Building an agile and sustainable supply chain requires the right technology and services that can monitor, measure, and optimize processes and efficiencies while reducing costs and carbon footprint.
For Controlant, the answer to each of the above key questions is: yes.
Controlant is an ISO 9001:2015 company, headquartered in Reykjavik, Iceland with operations in the U.S., Ireland, and Denmark. We deliver product quality, compliance, sustainability, and enhanced cold chain performance through our unique services-based partnership.
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