Adoption of a standard eData platform accelerates and facilitates sharing of raw material quality data and enables the end user to integrate data directly into internal knowledge management systems and process analytical tools. This allows for improved monitoring and analyses of production performance, better understanding of raw material impact to process and product variability, and more efficient investigations process for out-of-spec situations.
Setting the Stage for eData
The eMERGE™ Program, our standardized platform solution for the exchange of data, includes conversion of certificates of analysis (CoA) and certificates of quality (CoQ) into an XML machine readable format, based on an existing ASTM industry standard (ASTM E3077-17).
The eMERGE™ platform is compatible with existing Process Monitoring and Analytics Systems, including our Bio4C™ ProcessPad, a comprehensive data integration and process monitoring platform, providing you with a holistic experience from data collection through data analytics and beyond.
The eMERGE™ Program provides a:
- Secure and seamless eData exchange through a standard platform solution
- Standard file structure and data format providing consistency, reliability, and flexibility
- Foundation for implementation of advanced analytical and logistical solutions
Key benefits include:
- Elimination of human transposition errors
- Significant time savings based on data accessibility and direct integration with internal systems
- Reduction in process variability through raw material monitoring and trending analyses
- Improvements in various operational and process efficiencies, including real-time release and investigations
- Enablement of next generation biologics manufacturing, including predictive analytics and adaptive process control
Join the eData Movement
The implementation of eData across the industry is starting to gain momentum with the continued development of industry standards and key collaborations between major suppliers and manufacturers. Don’t be left behind, as eData will be a key foundation for the digital transformation of biopharmaceutical production analytical and logistical processes. Future expansion across the product life-cycle process could yield similar benefits from drug discovery all the way to patients.
Contact us today to learn more about the eMERGE™ Program and join the eData movement to enhance your digital transformation journey via a seamless, user-friendly and customer-centric digital experience. Obtain immediate benefits with integrated access to critical raw material data and build a foundation for development of future advanced analytical and logistical solutions across your entire supply chain.