Remote Auditing: How can the life sciences supply chain adapt?

Business operations in many industries have had to adapt to restrictions in place to curb the spread of Covid-19. While some operations can be paused until it is safe to resume normal practices, like working alongside colleagues or in-person trade shows, for many of the world’s critical industries, customers and suppliers must carry on communicating and collaborating. GxP manufacturing in the pharmaceutical industry has had to adjust to meet the challenges Covid-19 poses. The pharmaceutical supply chain, continuing to develop, test, manufacture, and ship medicine across borders around the world, has to ensure rigorous quality for these processes now, more than ever. To ensure this quality is achieved, supplier audits are performed both when on-boarding a new supplier and then periodically to track continued quality over time. These audits traditionally take place in-person, with customers visiting their suppliers (often across continents) to view manufacturing operations and review quality documentation, certificates, and process documents. With ongoing travel restrictions, pharmaceutical companies have had to quickly pivot to carrying out remote…

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Aoife Plunkett attended the MHRA GMP Virtual Symposium 2020

On the 2nd and 3rd December 2020, Veratrak’s Quality Assurance Manager, Aoife Plunkett, attended the MHRA Good Manufacturing Practice Virtual Symposium. The two-day event was packed full of informative and engaging talks, with a central focus on the effects of Covid-19 on quality and regulation in the pharmaceutical and life sciences industry. Several of the major topics on the symposium focused on areas where Veratrak is sought as a solution: exchanging GxP data remotely and securely and ensuring quality in operations from afar. The short timeline to change to an office-based inspection process, to accommodate Covid-19 restrictions, was particularly impressive, and highlighted the need for a secure method of documentation transfer, which email is unable to provide. The symposium included a series of speakers focused on innovation, with talks underscoring how the MHRA is committed to "support and enhance innovation and accelerate routes to market to benefit public health and be a magnet for life sciences." One session was dedicated exclusively to Distributed Ledger Technology, which explained the…

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