Purpose-driven data requirements for digital partnership in external manufacturing
When working towards digital partnership in external manufacturing it is tempting for sponsors to ask for "all" the data, just like they get from internal manufacturing plants. However, that is not practical because:
Sponsors must therefore think hard about the reasons why they instinctively want data, and we advocate a purpose-driven approach to specifying data requirements. By focusing on the purpose behind each data point, we can focus effort and create meaningful and efficient digital integrations. We'll explore how to align expectations, build trust, and optimize data interfaces to ensure everyone benefits.
Purpose-driven requirements
The foundation of identifying data point requirements lies in understanding the specific purposes for which the data will be used. This purpose-driven approach ensures that the data collected is relevant and valuable. Key questions to ask include:
By answering these questions, organizations can prioritize data points that directly contribute to decision-making, compliance, and process optimization.
Maximizing alignment on data point requirements
Achieving alignment on data point requirements involves confirming the availability and accuracy of mandatory elements, agreeing on optional elements, and considering controlled vocabularies for master data alignment. This process often starts with one product but should be scalable to accommodate future products and partners. The goal is to create a platform technology for digitalization that minimizes the need for customization.
To GxP or not to GxP?
Data used for Good Manufacturing Practice (GxP) purposes requires stringent validation to ensure its integrity and reliability. However, not all data needs to meet GxP standards. Organizations can implement two versions of the same interface: one for GxP data and another for non-GxP data. This approach allows for flexibility and ensures that only the necessary data undergoes rigorous validation, while other data can be used for broader analytical purposes.
Timeliness
The timeliness of data is critical for its usefulness. Some data needs to be available in near real-time, while other data can be processed in batches. Understanding the timeliness requirements helps in designing data transfer mechanisms that meet the needs of both sponsors and contract organizations. Establishing acceptable and unacceptable uses of near real-time data is essential for building trust and ensuring effective collaboration.
Governing data as a set of data products
in the 8 minute vie is a practical approach to digital integration. This involves understanding the full upstream and downstream lineage of the data, aligning business terms and taxonomies, and ensuring data quality and compliance. Data product managers play a crucial role in stewarding data across organizational boundaries, ensuring that it is used appropriately and effectively.
Conclusion
Identifying data point requirements is a critical step in the digital integration process for biopharmaceutical companies. By adopting a purpose-driven approach, maximizing alignment, considering GxP requirements, ensuring timeliness, and governing data as a set of data products, organizations can achieve successful digital partnerships. These best practices not only enhance efficiency and compliance but also foster a culture of collaboration and innovation in the biopharma industry.
Listen to Nitika Kaushal describe this in the 8 minute video clip below and share lessons from her experience as part of the DISCO playbook in a recent webinar.
Watch out for more short articles in this series, here on LinkedIn
Connecting the biopharm industry ? Coordinating collaboration ? Accelerating change
2 周It is great to see this work coming out of the BioPhorum IT Digital and Data Phorum - this is a great example of the collaboration across Phorum spaces in BioPhorum. The members of the Electronic Data Exchange and Digitization of the inbound supply chain workstream from the BioPhorum Supply Resilience Phorum were heavily involved in the DISCO work. This work is a forerunner to our BioPhorum Supply Resilience new workstream on CDMO Relationship Management workstream starting where the whole relationship aspects of the CDMOs and their License Holder sponsors is going to be worked on to seek best practices and new ways of working that will improve the relationship and the operational excellence for such an important relationship to work best for both parties involved ... and ultimately the supply chain and the people that rely on the supply of the biopharmaceutical therapeutics that we make and that they rely on to change their lives... If you want to know more then please contact me [email protected] #biophorum #biopharma #bioprocessing