Digital certificates of analysis & other transfers of quality test result data between organizations

Chapters:
0:00 Webinar and BioPhorum introduction
1:16 Introducing our presenters and agenda
3:38 What is DISCO?
11:17 Use cases of DISCO
19:25 The CoA problem
25:85 Vision user stories and benefits sought
40:34 The process of CoAs
52:46 Emerging standards
1:05:40 Data model
1:15:31 Realizations
1:22:31 Closing remarks
Download the full resource here 👉bit.ly/4as1kDW
This webinar by the BioPhorum Digital Integration of Sponsor and Contract Organizations (DISCO) program covers their work on Digital Certificates of Analysis and other transfers of quality test result data between organizations in the pharmaceutical supply chain.
it builds on the more generalized vision for digital integration of organizations previously presented.
- Understand the many use cases for Certificates of Analysis and related data in the pharmaceutical supply chain
- See the problem: pre-digital methods of transferring certificates are unsustainable and don't enable advanced analytical applications
- Grasp the vision user stories: what people need the data for in partnerships between our organizations
- See a reusable unified process flow that brings together traditional certificates and electronic and digital approaches
- Consider the emerging standards in this area, including E3077-17 and PQ/CMC
- See how a common data model can work to harmonize integrations between organizations
- Visualize how communication can be realized in several different ways, accommodating the diversity of digital maturity in our partner organizations
🗣️Our presenters:
- Nick Leggin, Associate Director, Business Technology Solutions, ‪@AbbVie‬
- Roland Kleinmaier, Senior Process Engineer, ‪@roche‬
- Maurice Prendergast, Innovation Consultant, ‪@GSK‬
- Stephen Wing, Head of Analytical & Logistical Services, ‪@Merck‬
- Heather Oliva, Senior Product Manager Digital, Resilience
- Ger Kierans, Quality Business Solutions & Data Analytics Lead, ‪@pfizer‬
- David Brick, Senior technical consultant
- Santul Sharma, Manager Business Systems (OT), ‪@LonzaGroup‬