DTG is proud to launch DASH, a digital platform that enables instant CoA data exchange between supply-chain partners, replacing slow email-based pdf exchanges of this critical quality information that governs the pace of product progression.
DASH is the first product from an Innovate UK-funded project with the University of Cambridge, GSK, GDP (now part of DTG) and CPI, tackling a data problem the sector has long recognised but been unable to fix on its own.
DASH, the Data Acquisition and Standardisation Hub, lets external supply chain partners exchange Certificate of Analysis (CoA) information as trusted, structured data rather than as the PDFs, spreadsheets and emails – twentieth century documents that are still being used to carry critical quality information between organisations. In a live demonstration that closed the Digital PharmaLink project, the assessment found this could cut review-to-approval cycle times by up to 90 per cent, with fewer errors and less manual rework.
Pauline Fallon is a former VP of Quality and Compliance at GSK and now works as an independent remediation, transformation and improvement expert across global pharmaceutical manufacturing sites. She explained the impact of manual Certificate of Analysis exchange:
“I see first-hand the pressure Quality leaders are under to move products faster, and how they keep getting held back by outdated ways of sharing critical information and disconnected data. And it’s not just inefficient – when you’re managing Certificates of Analysis at scale, manual errors and discrepancies can contribute to dozens of Quality deviations for organisations every year.”
DTG estimates that more than 100 million certificates are generated globally each year. That reliance on manual, document-led exchange is a recognised source of delay, rework and error and, because no single company can impose a common approach on all its suppliers and partners, it is a problem the industry has struggled to fix in isolation. This is why Innovate UK funded the Digital PharmaLink consortium to take it on and the result is DASH, now commercially available to all organisations in the global pharmaceutical supply chain.
Because it reads different document formats and communicates with different systems, DASH is designed to work alongside the enterprise systems organisations already use, rather than requiring them to replace that technology. Importantly, DASH also enables review by exception by the required number of humans in the loop.
DASH reads any CoA file format from any source system and automatically checks it against specific client standards. This enables the shift to review by exception and ensures documentation errors are not sent to the client before correction. Once the file is approved by the required humans in the loop, DASH instantly converts it to a machine readable XML file, accompanied by a human-readable view, with an immutable digital signature. DASH then securely transmits the XML CoA to any QMS or process at the receiving organisation, maintaining a forever-transaction log that captures responses and actions from every user for every CoA, ensuring data integrity and inspection-readiness.
Guy Wingate is former VP and Compliance Officer of Global Manufacturing and Supply, and author of Pharmaceutical Computer Systems Validation, now in its third edition from Taylor & Francis and pointed out the role of data integrity in Quality:
“Quality has always depended on confidence in the data behind every decision. Yet critical quality information is still exchanged through cumbersome processes and formats, including PDFs and emails, that add unnecessary effort and risk. DASH matters because it brings data integrity and control into the way quality data is exchanged between organisations. It is exactly the kind of practical digitalisation the industry needs: technology that makes quality processes work better in terms of efficiency, robustness and regulatory compliance.”
DASH was designed by an InnovateUK-backed, industry-led collaboration to enable faster, machine-readable data flow between sites and organisations with fewer errors – while accommodating any level of digital maturity in the supply chain. Click here to request a demonstration of DASH by our Technical lead at your convenience.
