With a focus on pharmaceutical supply chain regulation, Bonafi is one of the latest companies to launch within the regtech startup sector.
“Companies operating in the global pharma industry must verify that those they are buying from and selling to are authorised to handle medicinal products for human use in their own countries,” explains its founder, Katarina Antill. “At present, this verification process is manual. Companies are using screenshots as proof and relying on spreadsheets to track verification activities, which increases the risk of errors.”
“Manual processes are very labour intensive not least because companies must deal with multiple registries across multiple countries,” she says. “Most pharma manufacturers and wholesalers don’t have the resources to reverify their trading partners more than once a year, which is the current minimum legal requirement, and this too creates a potential vulnerability that can ultimately have an impact on patient safety and increase corporate risk.
“I could see that this huge volume of manual work was a threat to patient-safety and extremely inefficient,” she adds. “Our solution gives companies much greater control over their compliance activities because they no longer have to rely on manual processes. It can also retrieve and aggregate data from multiple registers across multiple countries and has a constant monitoring and alert system, quality management dashboards, electronic signatures and workflows and will strengthen the attributes of traceability, transparency and security. It is all designed to help companies to be pro-active in their compliance activities, enabling them to go beyond compliance alone to reduce corporate risk and patient risk.”
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Source: The Irish Times, 13 February 2020