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DASH平台将药品质量记录审批周期最高缩短90%,已商业可用

Digital platform cuts pharmaceutical quality-record approval times by up to 90%

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由Innovate UK资助、GSK、剑桥大学与CPI参与的Digital PharmaLink项目孵化的DASH平台已商业可用,可将药品质量记录审批周期最高缩短90%。DASH把PDF、Excel、CSV等格式的分析证书(CoA)转换为结构化数据,供供应链伙伴交换。结项演示由药品制造创新中心作为供应方、GSK作为接收方,完成数据转换、审核、批准、数字签名与安全传输。

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pharmafile | October 19, 2026 | News story | Pharmacovigilance, Regulatory Affairs |  Devices, Hospital Management, certification, digitalisation, pharmaceutical, regulatory, supply chain 

A digital platform for exchanging pharmaceutical quality records between supply-chain partners is now commercially available, following an Innovate UK-funded project involving GSK, the University of Cambridge and CPI.

DASH (Data Acquisition and Standardisation Hub) converts Certificates of Analysis (CoAs) from formats including PDF, Excel and CSV into structured data that can be exchanged between organisations. CoAs document the quality of materials used in pharmaceutical manufacturing and are checked as part of quality and batch-release processes.

A closing demonstration of the Digital PharmaLink project found that the platform could reduce review-to-approval cycle times by up to 90%, while reducing errors and manual rework. The demonstration involved the Medicines Manufacturing Innovation Centre acting as supplier and GSK as recipient, with data converted, reviewed, approved, digitally signed and securely transmitted.

The platform is designed to work alongside existing enterprise systems rather than require their replacement. It also supports review by exception, allowing quality teams to focus attention where checks are needed while retaining human oversight and existing quality controls.

The project brought together the University of Cambridge, GSK, specialist developer Good Digital Practice, now part of DTG, and innovation centre CPI. It aimed to address the difficulty of exchanging standardised quality data between organisations using different systems and document formats.

Rob Innes, Director of Data Analytics and AI at DTG, said pharmaceutical manufacturers had invested heavily in digital systems within individual sites, but exchanging information between organisations remained a challenge.

DASH initially focuses on CoAs, although its developers intend to extend the approach to other quality data exchanged across pharmaceutical supply chains.

Pic: Vitaly Gariev

来源:Pharmafile · pharmafile.com