D2-UC1: Batch Tracking
Introduction
The IMDP ontology covers the domain of a Medicinal Product & Substances in great detail, expansion of this to cover the broader Chemistry, Manufacturing and Controls (CMC), would allow expansion knowledge graph to batch and supply chain based on data from Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) in addition to the information currently taken from the Regulatory Information Management (RIM). This would batch, materials and product data in to a single source, allowing for example automated genealogy as demonstrated with this pattern, thereby minimizing manual reconciliation, risks and faster more reliable impact assessments and implementation of changes.
Related Competency Questions
- D2-UC2-CQ1: What <material x> does this <lot y> represent?
- D2-UC2-CQ2: Was this <lot x> manufactured or procured <situation y>?
- D2-UC2-CQ3: <When x> was this <lot y> made?
- D2-UC2-CQ4: Which <lot x> are made by our <contract manufacturing network x>?
- D2-UC2-CQ5: Which <Bill of Materials x> documents the materials of this <Lot y>?
- D2-UC2-CQ6: What was the <Recipe x> used to make this <batch y>?
- D2-UC2-CQ7: Which <lots x> were used to make this <lot y>?
- D2-UC2-CQ8: Which process <step order x> was used to make this <lot y>?
- D2-UC2-CQ9: What is the <cost x> of this <lot y>?
- D2-UC2-CQ10: What is the <shelf-life x> of this <lot y>?
- D2-UC2-CQ11: What is the vendors <lot number x> for a procured <lot y>?
- D2-UC2-CQ12: Which <manufacturer x> & <facility y> made this <lot z>?
- D2-UC2-CQ13: Which <facility x> <line y> <equipment z> made this <lot a>?