The following summary is from a panel discussion hosted by the ELPRO Leading Minds Network as part of its Temperature Control Tuesdays™ programming in partnership with Cold Chain Platform and PCI Pharma Services. This session featured Henry Moran, ASC Associates Ltd. (moderator); Emanuel Schäpper, ELPRO; Iris Sioson, Envirotainer; Michael Lopez, Medytox; and Stefan Braun, SmartCAE.
The summary will provide answers to the following questions posed to panelists:
How to achieve end-to-end supply chain visibility in temperature-controlled logistics
How to ensured and prove data integrity to auditors when temperature data are merged from many sources and different systems
How to analyze and identify supply chain improvement potential with temperature monitoring data of environmental conditions during transportation?
Conventional monitoring, real-time technology or a combination of both? Achieving end-to-end supply chain visibility in temperature-controlled logistics
End-to-end supply chain visibility means that supply chain stakeholders have visibility into the entire process of supplying customers, from sourcing parts or raw materials to bringing those materials to manufacturing and ultimately to customers. The panelists clearly see the benefits of real-time monitoring for supply chain visibility. However, by itself, it does not make for success. Why?
Two aspects need to be considered in terms of visibility:
Logistics visibility requires immediate data, but also control towers to react in case of deviation;
Stability visibility requires highly secure data, which may well be retrospective, to release a shipment ‘as good’ in the end.
Regarding stability visibility, companies are certainly capable of achieving visibility with conventional temperature monitoring solutions. It is possible to collect data, merge it, gain visibility over parts of the supply chain, sections or the entire supply chain, and evaluate the entire data collection against profiles. However, this has always been retrospective and therefore not sufficient for logistics visibility. That's why real-time monitoring of temperature, humidity and even location has been on the logistics industry's wish list for years.
However, there are still many technical gaps and problems to overcome. For example, in certain areas there are problems with the wireless connection from the hardware to the central station/server. All the integrated partners in the supply chain need to get together and ask how we can overcome these logistical challenges. It can't be a stand-alone solution.
And that brings another challenge up to the surface: collaboration. Transparency only emerges when supply chain actors work together and involve each other in their processes, sharing data and ensuring that information is transparent to all parties. However, sharing real-time data is not yet a given for everyone. Often, insight into this real-time data is limited by the fact that temperature reports are sent only after delivery, thus a retrospective solution.
Collaboration and transparency part between the stakeholders is the key to visibility.
Iris Sioson, Envirotainer
Real-time monitoring is a real added value if, in addition to this, proper baseline planning has been done, scenarios have been analyzed, potential risks have been identified, and risk mitigation plans have been made. Then real-time monitoring is the final level of protection. And it can be very valuable in unplanned cases.
If baseline planning is 98% bulletproof, then real-time monitoring can cover the remaining 2% that can really happen in the real world.
Stefan Braun, SmartCAE
Compliant documentation of data vs. digitization for efficient reuse and sharing. Ensuring and proving data integrity to auditors when temperature data are merged from many sources and different systems
Companies face the challenges of documenting data compliantly and securely to be best prepared for future audits. They also need to digitize that same data for their own reuse and sharing within the supply chain.
For all data used for the re-evaluation and release of products, the following applies: they must remain untouched. Therefore, this data has to be saved and stored as one package according to regulations. Auditors prefer an unalterable "snapshot" of the data or proof signed by a quality representative, a date stamp with a signature to authenticate the data, and some traceability to a second person or a verification step. PDF files are a well-established and secure data package fulfilling all these requirements.
A lot of digital data and digital formats are [still] an alert to auditors that changes could happen and they may not be able to chart the changes.
Michael Lopez, Medytox
However, in order to continue working with this data, to make it transparent and accessible to other supply chain stakeholders, it must be digitized. And with more and more incoming digital wireless data, companies need to find an efficient way to prove that this has not been tempered with and to turn all this into actual records or traceable data that can be verified (second person verification step).
We need to ensure that this has not been tampered with, because that is what our auditors will be asking.
Iris Sioson, Envirotainer
In terms of data sharing integrity, supply chain stakeholders should know exactly when they should really keep their data closed and at what point they want to allow the data to be opened to others for processing.
An existing solution is PDFs with embedded digital data that can be easily extracted. Companies can work with the digital data and still always have the unalterable original. The problem here is that different providers handle this completely differently. So you can't rely on a guaranteed system. Here, too, close cooperation between the participants is required for the future, as is the definition of standards so that these systems can be validated.
External data loggers, real-time technology and simulations. Analyzing and identifying supply chain improvement potential with temperature monitoring data of environmental conditions during transportation
In addition to temperature data, data on other important environmental conditions can make all the difference in monitoring. Has a door been opened? And if so, why? How could we avoid this in the future? Did the truck driver travel from the production site directly to the airline's terminal or first go to their warehouse to store the container? And if so, could this be avoided next time by fixing it right with the order?
These new collected ambient data from rooms and shipments can be used to run virtual simulations. In the past, data was collected, documented and archived. Only later did people realize how valuable this data was in order to use analysis and reporting tools, dashboards, etc., to find corrective actions and potential for improvement.
This retrospective data is now being supplemented by real-time data. An enormous amount can be learned from combining the two, and utilizing simulations, to minimize packaging costs, for example. Adjustments to various service levels can also be improved if it is discovered that the supply chain is over- or under-engineered.
Access to real-time data provides several opportunities:
Ability to intervene
Risk planning in advance
Analysis and planning to improve future shipments
In some cases, the loss of a shipment can cost pharmaceutical companies millions of dollars. If a particular situation occurs during a shipment, companies can use data from previous shipments to predict how it might end up. This predictive analysis makes it possible to decide more quickly what measures to take to save the shipment or, in the worst case, to replace it with a new one.
At the end of the day what we want to make the supply chain more robust.
Stefan Braun, SmartCAE
The collection of data via the data loggers often ends when the product is handed over to the pharmacy or hospital. But even after that, manufacturers are interested in ensuring that the product is also protected during the so-called last mile. This is a real challenge! Much better work needs to be done here by identifying vulnerabilities on site, improving training, sharing information, and providing help when needed.
We are talking about a fully transparent digital supply chain that can help identify where perhaps simple changes can dramatically improve the supply chain.
Stefan Braun, SmartCAE
When it comes to realizing an intelligent pharma supply system and visibility of the entire product flow, from manufacturing to warehouse to distribution center to healthcare facilities, the key is how data are handled from a technical and human perspective.
For sure, technical solutions must be found. Mobile IoT will spread. It will become available in more and more countries and open up opportunities for both transport monitoring and onsite monitoring. However, regardless of the technical possibilities, people ultimately have to share their data. Otherwise, all that data are collected and end up in silos that can never exploit its true value. There needs to be collaboration across all segments.
Technology might not be the problem, rather the will to cooperate.
Stefan Braun, SmartCAE
Supply chain stakeholders need to make sure they have sufficient resources to use all this technology and the resulting data. How can these people be trained? How do we leverage technology to improve knowledge management and reduce costs? How do we need to improve processes and risk management? Are we going to have a skilled team that is really engaged in knowledge management and using all of this in a meaningful way to help the various stakeholders in the supply chain? How can the various stakeholders work together to bring the data together and ensure data integrity? What fears need to be overcome to make data sharing a reality?
Only on the basis of this changed attitude will the industry's wish list for the future be feasible: integrated systems between all stakeholders.