Vegam Pharma MOM connects batch execution, materials, equipment, process data and quality workflows into one controlled manufacturing context.
The losses live between departments, not inside them. ERP plans, automation runs the equipment. Vegam SFS executes and orchestrates everything in between.
QA reconstructs the BMR, in-process results, deviation closures and CoAs from separate systems before a batch can ship.
The EBR executes with the batch, not after it. Parameters, checks and signatures captured against the master recipe as work happens, so the release pack assembles itself.
Found at review, days after the event, with no linked view of the materials, equipment, operator or prior occurrences involved.
Exception-driven operations. Deviations captured at the point of execution, routed through configured escalation paths, and linked to full batch genealogy, equipment state and CAPA history.
Separate MES, LIMS, QMS and ERP each keep their own record. ALCOA+ breaks in the seams between them.
One governed data model across the plant. ALCOA+ by construction: audit trail, electronic signatures and role-based access.
Semi-automated, fully automated, CMO-dependent, legacy-constrained. Corporate templates either force a model plants can’t run or fragment into local builds.
The harmonising layer. Corporate fixes the data model, KPIs and compliance; each site configures workflows, equipment and CMO steps inside those boundaries. Configuration, not forks.
Layered over fragmented data, AI produces plausible answers with no operational grounding. Pilots stall and trust erodes.
MOM governs actual execution, so high-fidelity operational data is a byproduct of running the plant, not a separate project.
Eight stages from goods-in to release, with the quality gates visible rather than implied. Click a stage to see the operational reality, and what changes when the record builds as the batch runs.
Every execution step captures its value, expected limit, result and attribution in context. No end-of-batch reconstruction.
Illustrative record. Batch, lot, recipe and deviation identifiers are examples.
The record follows the process, not the paperwork.
Everything that conformed stays in the record. Only what needs judgement reaches the reviewer, with its context already assembled.
Illustrative review scenario. Values are examples, not customer data.
By the time the batch reaches disposition, the pack is complete. QA is making a decision, not compiling one.
Illustrative disposition. Values are examples, not customer data.
From digital twins to regulatory compliance, the platform covers every aspect of pharmaceutical manufacturing.
Audits by regulators: no more a pain
AI/ML-driven insights for better decisions
Paperless execution and compliance
Monitor and optimize performance
Mobile-first maintenance workflows
Complete material traceability
Brownfield PLCs and SCADA connect without modification, and no system of record is replaced.
21 CFR Part 11 · EU Annex 11 · ISA-88/95 · ALCOA+ · CSV-ready
Production, quality, lab, warehouse and maintenance. Not six tools.
Corporate governs the model; each plant configures its reality.
On-prem or private cloud. Nothing leaves your boundary.
Zero big-bang cutover. Run in parallel with existing systems, prove equivalence on one line, and expand without a plant-wide migration.
Digitise the logbooks that run the floor every shift. Inspection-ready from day one.
Production orders in, batch completion out. No system of record replaced.
Recipe-driven execution, dispensing and in-process checks on one record.
Warehouse, quality, maintenance and utilities on one operating model.
Full automation integration, and the governed context AI runs on.
No. Vegam SFS sits on your systems of record and integrates through pre-built connectors. Nothing is ripped out.
Delivered with a GAMP 5 CSV package: IQ, OQ and PQ protocols, requirement traceability and validation summary reports your QA can execute.
Yes. Deploy on-prem or in a private cloud. Records stay inside your boundary, with data residency by design rather than as a workaround.
Your GxP records are yours. Every batch record exports audit-ready, and structured data exports through open APIs. No proprietary lock-in.
A focused walkthrough against your real operation: your products, your batch records, your deviations.