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 methodology, and resultant security and data integrity of using blockchain to record data. Veratrak was consulted by the MHRA to provide expertise and content outlining GMDP applications of blockchain to highlight existing applications of the technology in the industry, such as ensuring audit logs are immutable and tamper-proof.
Key takeaways from the symposium:
Remote inspections and audits are occurring, and require the transfer of commercially sensitive documentation. The file transfer system used must have appropriate quality and security control.
COVID-19 has highlighted the need for adoption of digital tools to collaborate securely with colleagues, suppliers, and customers, from anywhere.
Distributed Ledger Technology can be used to securely share GMP data between supply chain members to enhance data integrity, and generate an immutable audit trail of all events.
Veratrak is committed to solving these challenges. Get in touch to find out how we can improve collaboration, security, and visibility outside the walls of your business.