Standard for Quality and Regulatory Documentation (StaQRD)

Welcome to a New Era of Data Transmission

Supporting our customers in supplier selection, material qualification and risk assessment is at the heart of our Emprove^® Program. As regulations evolve and industry guidance progresses, we continuously innovate to enable our customers to make more agile, risk-based decisions. Supplying customers with convenient access to a broad product portfolio complemented by reliable quality and regulatory information, the Emprove^® Suite has already made important steps towards Pharma 4.0 and Smart Quality. In collaboration with BASF Pharma Solutions, we’re now taking convenient access to information to a whole new level. Together we have developed StaQRD, an industry-pioneering eData standard that enables us and other suppliers to automatically transfer up-to-date quality and regulatory documentation in a standardized format to pharmaceutical and biopharmaceutical manufacturing customers. 

Why We Need a New eData Standard

When receiving information, stakeholders such as Supplier Quality, Quality, Procurement, Regulatory and Patient Safety currently have to deal with a variety of human-centric document formats such as PDF and Microsoft Excel. These formats are neither designed for automated data processing nor standardized across the industry, which hampers digitalization ambitions, especially at the supplier-customer interface. Together with our collaboration partner BASF Pharma Solutions, we have therefore taken action to overcome the challenges of heterogeneous information formats and manual processes. Inspired by a vision of eliminating tedious manual information processing, our teams combined their expertise and experience to create a pioneering new industry standard: a universal eData format that is compatible with various information systems and that enables process automation.

Entering a New Level of Efficiency: StaQRD

Our pioneering eData standard guide is available free of charge to all suppliers and manufacturers across the pharmaceutical and biopharmaceutical industries. The new standard is set to change the way we collectively manage, communicate and process quality and regulatory documentation. It establishes an elaborate data schema and allows quality and regulatory documentation to be provided in a machine-readable Extensible Markup Language (XML) format. The Standard for Quality and Regulatory Documentation (StaQRD) thus enables machine-to-machine communication and process automation. Leveraging the electronic transfer of data, StaQRD will pave the way for streamlining critical communication processes between suppliers and customers in our industry. 

Key Features

The new eData standard significantly facilitates supplier selection, material qualification, and risk assessment. At its core, the eData standard introduces a harmonized eData notation for critical quality and regulatory information that can be provided on the product or component level.

What quality and regulatory content is included in StaQRD?

• Aflatoxin
• Allergen
• Genetically Modified Organisms (GMO)
• Good Manufacturing Practice (GMP)
• Manufacturing Procedure
• Melamine
• Nitrosamine
• Product Specification
• TSE/BSE

Your eData Opportunities – Request Download

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