BASF Pharma Solutions, life science business of Merck KGaA launch new standard for electronic exchange of quality and regulatory data
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
BASF Pharma Solutions and the Life Science business of Merck KGaA, Darmstadt, Germany announced the launch of a new standard for the electronic transfer of quality and regulatory documentation from suppliers to users in the pharma/biopharma industry. The Standard Quality and Regulatory Documentation (StaQRD) electronic data standard includes quality and regulatory compliance data.
A company statement informed, “A previous eData standard, ASTM-E3077, published by the American Society for Testing and Materials (ASTM), was primarily designed for transferring CoA content and did not include the exchange of additional information. Building on this CoA standard, StaQRD includes nine additional types of compliance documentation in the initial launch, such as nitrosamine risk assessment, allergen statements and GMP compliance documents. StaQRD is available to all suppliers and manufacturers with the goal of facilitating a streamlined electronic documentation exchange while ensuring data integrity, speed and efficiency, and flexible data management.”