Let me provide a comprehensive overview of how we implemented this solution and the key architectural decisions that made it successful.
Electronic Batch Record (EBR) Architecture: We designed the batch record structure in HM to mirror our paper batch record format, which made regulatory acceptance easier. Each EBR contains sections for material identification, process parameters, quality checkpoints, and operator signatures. The material management module automatically populates lot numbers and quantities as materials are consumed at each process step. This creates a complete digital record that satisfies 21 CFR Part 11 requirements for electronic records.
API-Based Integration Framework: We built the integration using the HM 2023.1 REST API for material management operations. The architecture uses a middleware layer running on our integration server that orchestrates the data flow between HM and SAP. This middleware handles the transformation of HM batch record data into SAP-compatible formats and manages the bidirectional synchronization. We chose REST APIs over direct database integration to maintain system integrity and ensure we’re using supported interfaces that won’t break during upgrades.
Material Genealogy Tracking Implementation: The genealogy tracking captures parent-child relationships at multiple levels. When raw materials are issued to a batch, the system records the supplier lot numbers. As materials move through processing steps, we track transformations including blending, reactions, and packaging operations. Each transformation creates genealogy links showing which input lots contributed to which output lots. This creates a complete traceable chain from raw material receipt through finished goods shipment.
The genealogy data structure includes lot number, material code, quantity, unit of measure, process step, timestamp, and operator ID for every material movement. We also capture equipment IDs and process parameters like temperature and pressure that are critical for batch record completeness. All of this data flows to SAP where it’s stored in custom tables linked to SAP batch records.
Compliance Audit Automation: The real value emerged during our first audit after implementation. We created several pre-built queries that auditors commonly request: forward traceability (where did this raw material lot go?), backward traceability (what raw materials are in this finished goods lot?), and cross-lot analysis (which batches used material from a specific supplier?). These queries execute in seconds by joining the genealogy tables in SAP.
We also implemented automated batch record completeness checks that run nightly. The system verifies that every production batch has all required data elements, flags any missing signatures or quality results, and generates exception reports. This proactive validation means we catch and correct issues immediately rather than discovering gaps during audit prep.
The compliance team now maintains an always-audit-ready state instead of scrambling for weeks before inspections. Our audit preparation time dropped from 3 days to 4 hours because we’re just reviewing the automated reports rather than manually compiling data. The automated genealogy tracking has also enabled faster response to customer quality inquiries and potential recall scenarios - we can now identify affected lots within minutes instead of days.