Case Study
Paper to Electronic Batch Record — PAS-X MES and SAP Integration for a Pneumococcal Conjugate Vaccine PPQ Campaign
The Challenge
A PPQ campaign is a regulatory liability on paper.
A GMP vaccine manufacturing facility was preparing to run a Process Performance Qualification campaign for a complex 14-valent pneumococcal conjugate vaccine — the critical validation milestone required before regulatory submission and commercial launch. The facility was operating entirely on paper batch records.
For a standard commercial batch, paper batch records are an administrative burden. For a PPQ campaign, they are a regulatory liability. PPQ batches are the batches regulators use to assess process consistency and control. The executed batch records become primary evidence in the submission package. FDA and EMA reviewers expect data that is traceable, attributable, contemporaneous, original and accurate — the ALCOA+ standard that paper records structurally cannot meet. Manual transcription introduces errors. Manual review introduces delays. And a paper batch record assembled after the batch has run cannot demonstrate the real-time process control that a PPQ package needs to show.
The facility needed to move from paper to electronic batch records before the PPQ campaign ran — not in parallel, not as a trial. The EBR had to be the system of record for every PPQ batch. And it had to be connected to SAP so that raw material identity, lot traceability and batch disposition were managed electronically end to end. The timeline was fixed. The PPQ campaign could not move. The MES implementation, the SAP integration and the validation all had to be complete before the first PPQ batch ran.
The Scope
Our Process Automation Engineers implemented Werum PAS-X MES as the electronic batch record system for the pneumococcal conjugate vaccine process — a complex, multi-step conjugation process with tight in-process controls and a large number of manual data entry points in the paper system, each one a potential source of transcription error or documentation gap.
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PAS-X master batch record design and build
The master batch records were designed and built in PAS-X from the ground up — not as a paper-on-glass reproduction of the existing paper process, but as a properly structured electronic execution framework. Guided operator steps replaced every manual data entry point. Automated data capture was configured wherever the process control system provided a value directly. Role-based electronic approval workflows replaced the manual QA review chain.
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SAP integration — material identity, lot genealogy and batch disposition
The SAP integration was configured through PAS-X standard interfaces — connecting raw material lot identity, material traceability and batch disposition between MES and ERP. Every raw material was electronically identified and confirmed at the point of dispensing. Lot genealogy was automatically captured in the PAS-X batch record without manual entry. Batch disposition was managed through the integrated PAS-X-SAP system — so the path from batch completion to QA release was electronic, traceable and complete from raw material to finished product.
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Validation and PPQ readiness
The system was validated and live before the PPQ campaign started. The PPQ batches were executed entirely on the electronic system — PAS-X EBR was the primary batch record from the first PPQ run, with no paper shadow process running in parallel.
The Outcome
- ~60% reduction in batch review time
- Zero manual transcription errors across PPQ scope
- ALCOA+ submission package built from EBR data
The PPQ campaign produced electronic batch records that were complete at the point of batch completion — automatically generated, fully traceable through the PAS-X-SAP integration and ready for QA electronic review without manual data compilation.
The transition from paper to electronic batch records dramatically shortened the path from PPQ batch completion to regulatory submission readiness. A review process that had previously required weeks of manual assembly and sequential QA sign-off was replaced by a structured, immediately reviewable electronic record — complete at the moment the final process step was executed.