Case Study
PBR to EBR — PAS-X MES and SAP Integration, Vaccine Conjugate PPQ
The Challenge
A PPQ campaign is a regulatory liability on paper.
A GMP vaccine facility was preparing to run a Process Performance Qualification campaign for a complex 14-valent pneumococcal conjugate vaccine — the critical validation milestone before regulatory submission and commercial launch. The facility was operating entirely on paper batch records.
PPQ batches are the batches regulators use to assess process consistency and control. The executed records become primary evidence in the submission package — data that must be traceable, attributable, contemporaneous, original and accurate. The ALCOA+ standard that paper records structurally cannot meet.
The facility needed to move from paper to electronic batch records before the PPQ campaign ran — with the EBR as the system of record for every PPQ batch, connected to SAP for raw material identity, lot traceability and batch disposition, end to end. The timeline was fixed.
The Scope
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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 a paper-on-glass reproduction of the existing process, but a properly structured electronic execution framework. Guided operator steps replaced every manual data entry point, automated data capture was configured wherever the control system provided a value directly, and role-based electronic approval workflows replaced the manual QA review chain.
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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 a paper-on-glass reproduction of the existing process, but a properly structured electronic execution framework. Guided operator steps replaced every manual data entry point, automated data capture was configured wherever the control system provided a value directly, and role-based electronic approval workflows replaced the manual QA review chain.
-
PAS-X master batch record design and build
The master batch records were designed and built in PAS-X from the ground up — not a paper-on-glass reproduction of the existing process, but a properly structured electronic execution framework. Guided operator steps replaced every manual data entry point, automated data capture was configured wherever the control system provided a value directly, and role-based electronic approval workflows replaced the manual QA review chain.
The Outcome
- ~60% reduction in batch review time
- Zero manual transcription errors across PPQ scope
- 1st batch on EBR — no paper shadow process
The transition 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.