The following is an executive summary of the full Sensitech® white paper: Digital Transformation of the Cold Chain: Introducing Interoperability While Protecting Life Sciences Product Release Data.
The world’s leading industrial and manufacturing companies are now engaged in the process of digital transformation. They are discovering that the application of digital technologies can help reduce costs, increase efficiencies, enhance customer value, manage risk and improve supplier, partner and customer relationships.
In the Life Sciences industry, digital transformation presents both an opportunity and a risk for companies who have spent decades building compliant cold chain processes.
The opportunity – and its benefits
Inexpensive sensors and the Internet of Things (IoT) have created new sources of data that can be combined in novel ways to enable growth and improve margins. And many cold chain monitoring companies now offer interoperability between systems that collect supply chain data, where information from any third-party sensor or a datalogger can be integrated into a single database.
For Life Sciences companies, the analysis of large volumes of data like this presents them with an opportunity to reduce costs, enhance data flows, and improve business decision-making across their supply chains. The huge volumes of data now being produced in the digital world, and in specific, for cold chain analytics, allows for temperature measurements to be combined with other significant data. Companies are integrating cold chain data it with environmental inputs, location data, other transportation and logistics information, and applying powerful algorithms to yield fresh insights into cold chain performance.
The risk – is it worth it?
The very interoperability that drives this opportunity also poses a risk for Life Sciences companies who are obligated to segregate and protect validated cold chain data that is used for product release decisions and regulatory compliance.
Therefore, to achieve what might be a gain in new insights may require new ways of accessing and protecting data and maintaining the integrity of a validated system used to make product release decisions. Ideally, a Life Sciences industry trade group or organization would come forth and establish specific formats and standards that comply with and are approved by industry regulators. But until such standards are established, Life Sciences companies engaging in interoperability put their validated data at significant risk.
The answer? Look for a solution with a validated database
Cold chain monitoring and analytics companies rely on the U.S. Food and Drug Administration’s (FDA) rule on electronic records and signatures (21 CFR Part 11) and the European Medicine Agency’s Guidelines to Good Manufacturing Practice—Annex 11 regarding computerized systems. When following these same guidelines, temperature monitoring companies can create proprietary databases that are fully validated and designed to meet the regulatory requirements for product release decisions.
An optimal temperature monitoring solution is, in effect, an end-to-end, sensor-based, risk mitigation system. It can provide consistency, reliability, accuracy, traceability, and validation of cold chain data. The introduction of new practices such as interoperability can be built into the requirements for data integrity. Organizations recognize that while many supply chain planning decisions can be enhanced by mixing and matching various third-party sensors, the data must be validated according to industry standards in order to support product release decisions that are compliant.
Life Sciences companies who are considering a cold chain solution that offers interoperability should ask potential vendors these questions in order to reduce their risk:
- Who ensures that third-party devices remain validated?
- Who ensures that all validation documentation and artifacts are maintained?
- Who is responsible for validating new sensors?
- Will advanced notification be required for any and all changes to sensors and software, even those that do not constitute a new product introduction? How might changes in advanced notification impact the underlying costs to provide a monitoring program, and the ability to adapt to changing conditions?
- If a company alters or improves its monitor, how will validation be assured?
- How are product release decisions made with inconsistent or incompatible data from two or more suppliers?
- How will differences in measurement precision, time-zone calculations, rounding, conversion from Fahrenheit to Celsius, or other differences in monitor specifications be reconciled?
- How will regulators view interoperability?
At some point, when the industry makes validation mandatory with interoperability solutions, these questions won’t be necessary. But until then, they are, in and of themselves, mandatory.