Pharmaceutical manufacturers are turning toward digitized data collection and integrated solutions to meet regulations, improve visibility into their operations, and create a more transparent supply chain.
According to a new report from PMMI Business Intelligence, “Pharmaceutical Manufacturing, Trends Shaping The Future,” nearly half of the pharma manufacturers interviewed are collecting at least some data digitally now, with a handful of operations at leading manufacturers gathering 100% of their data digitally. Of course, this also indicates that half of the pharma companies included in the survey are doing no digital data collection, proving the adage, change comes slow to the pharmaceutical industry.
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“We have fifteen lines and only three are integrated; we will continuously upgrade until all lines are integrated and collecting data digitally.“
— Production Engineer, Large OTC Manufacturer
DSCSA and Digitization
The Drug Supply Chain and Security Act (DSCSA) has been one of the hottest topics in the pharmaceutical industry in recent years, especially as full serialization and aggregation requirements take effect in 2023.
This is not news for pharmaceutical manufacturers, who have been aware of the regulations for years now. Many have already addressed DSCSA requirements through integration and digitization, with 60% of companies interviewed stating they are already fully compliant with coming aggregation requirements. This leaves a notable 27% of companies interviewed still requiring changes to meet DSCSA requirements (the remaining 13% do not fall under DSCSA regulation).
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For companies already in compliance, the digitization necessary to meet DSCSA aggregation requirements can be viewed as an important stepping off point to further expand the digitization and collection of data across an enterprise, or to store and analyze collected data more efficiently.
For companies still needing to come into compliance, the requirements of DSCSA can be seen as an opportunity to achieve two goals at once. These operations can benefit immensely from looking beyond DSCSA to a digitized future, selecting “future-proof” machinery and improvements that will not only address immediate regulations, but also open the door to the proliferation of digitization and integration across operations. In either scenario, suppliers have significant opportunity to assist pharmaceutical manufacturers in proactively planning improvements and purchasing equipment that enables the continued expansion of digitization in the future.
“We will be serialization compliant by next year once we upgrade both hardware and software for case packers.”
--Associate Director, Packaging Technology, Large Biopharmaceuticial Manufacturer
Cybersecurity Looms Large
Cybersecurity is one of the largest concerns for all manufacturers, pharmaceutical companies are no exception. In a recent survey, 70% of pharmaceutical companies stated that cybersecurity is currently one of their largest operational concerns. This is a particularly critical issue for pharma with large troves of proprietary patient data, some collected remotely.
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According to PMMI’s report, says Paula Feldman, Senior Director, PMMI Business Intelligence, “It’s critical that industry stakeholders work together to secure large, permanent data repositories shared by manufacturers, as well as make wireless communications between patients, manufacturers, pharmacies, and care providers more secure.”
Source: PMMI Business Intelligence, Pharmaceutical Manufacturing, Trends Shaping the Future
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