StaQRD™ – Standard for Quality and Regulatory Documentation

Within the pharmaceutical and biopharmaceutical industries, the exchange of quality and regulatory data and documentation is often manual.

Suppliers and customers send paper documents and PDFs via email, resulting in a lack of speed, potential data quality issues, and other inefficiencies.

To simplify information exchange in a digital way, BASF Pharma Solutions and Merck KGaA, Darmstadt, Germany have collaborated to develop a common standard guide on how suppliers and customers throughout the industry can best exchange electronic connections for quality and regulatory content: StaQRD™.

With StaQRD™, suppliers and manufacturers can use a common language to exchange electronic data, or eData , transferring compliance documentation seamlessly between suppliers and customers.

To best benefit the industry from such joint common language, we offer the standard for free and open to use for all pharmaceutical and biopharmaceutical suppliers, manufacturers and authorities.

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Benefits of eData exchange

Speed and Efficiency

Eliminates the need for manual exchange of quality and regulatory data and documentation via email or mail. Customers receiving eData can instantly access and use content.

Data Quality and Integrity

Reduces risk of data quality issues. Customers are linked directly to suppliers, ensuring content and documentation is up to date.

Flexibility

Customers can access eData from their own quality and regulatory systems.

Video
Learn more about StaQRD™

Get a quick overview of how StaQRD works and can benefit your business in this short video.

Video: Introducing StaQRD™ - Standard for Quality and Regulatory Documentation
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What is e-data?

eData is the electronic transfer of data between machines. With eData, suppliers and customers can directly transfer quality and regulatory content, directly within their specific quality and regulatory systems.

This creates the potential for significant efficiency gains between suppliers, customers, and authorities.

The key advantage is that eData can be directly read by computers/software and thus eliminates manual or cost-intense efforts to convert document into machine readable data.

BASF and Merck KGaA, Darmstadt, Germany have collaborated in the development of a common eData standard for quality and regulatory content, StaQRD™, and will jointly share a guide supporting the usage across the pharmaceutical and biopharmaceutical industry.

Join us in this journey! We are looking for additional collaborators across the industry willing to support the further development and use of StaQRD™.

You can contact us here.

This new defined standard of converting document content from static pdf formats into machine readable content, called StaQRD™, creates standard eData connections for quality and regulatory content, and enables e-transfers between manufacturers, suppliers, customer systems, and regulatory authorities.

StaQRD™ is a free guide, available and open to use to all suppliers, manufacturers and authorities across the pharmaceutical and biopharmaceutical industries.

  • Aflatoxines
  • Allergens
  • Genetically Modified Organisms (GMO)
  • Good Manufacturing Practice (GMP)
  • Manufacturing Procedure
  • Melamine
  • Nitrosamine
  • Transmissible Spongiform Encephalopathy (TSE)/ Bovine Spongiform Encephalopathy (BSE)
  • Product Specification

The BASF and Merck KGaA, Darmstadt, Germany teams continue to add more compliance documentation to the StaQRD™ guide. Please reach out to the BASF or Merck KGaA, Darmstadt, Germany StaQRD™ team to learn more, have requests for additions or want to join us to further develop StaQRD™.

Contact Us

Have questions? Connect with a BASF eData expert.

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