About the company
Bruni Manufacturing Systems supports pharmaceutical manufacturers in designing, integrating and validating the digital systems that run regulated production.
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Engineering-led
We work at the intersection of automation, IT and quality — turning operational requirements into GMP-compliant digital systems.
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Compliance by design
Every system is built to hold up under inspection, with documentation and validation support aligned to the client’s quality framework.
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Scoped to fit
Engagements range from sigle-site MES and DCS engineering to multi-vendor, multi-site program coordination.

We help manufacturers move from paper-based processes to connected, standards-based digital manufacturing — designing MES recipes, integrating shop-floor systems with ERP and LIMS, and coordinating the vendors and system integrators involved along the way.
Our focus is Drug Substance and Drug Products – Food&Beverage and Power&Energy – manufacturing environments, where system changes have to satisfy both operational and regulatory requirements at once. That means documentation, validation and change control are built into the engineering work, not added afterward.
Bruni Manufacturing Systems is built to bring senior, hands-on expertise to organizations that need it — for a single project or an ongoing program.
Let's talk about your manufacturing systems.
Whether it’s a single MES recipe, an OT/IT integration, or program management across multiple sites — get in touch to discuss scope.
Services
Manufacturing Systems
MES & Recipe Engineering
- MES design, configuration & engineering (PAS-X, POMs, Tulip)
- MES Recipe Authoring (PAS-X, POMs, Tulip) — master recipe design and configuration
- Paper-to-Digital transformation — migration from paper-based batch records to electronic batch records and digital workflows
Data Integration & Architecture
- OT/IT integration — DCS (DeltaV, PCS7, Foxboro, Schneider Electric), PLC (Siemens, Allen-Bradley), BMS/EMS
- Historian – OSI PI
- Manufacturing Data Gateway installation — Ignition, HighByte, COPADATA
- Manufacturing Data Standardization (ISA-95/88) — harmonized data models across sites for Manufacturing SW
- Alarm Management — rationalization and design aligned with ISA-18.2
- Enterprise system integration — SAP ECC/S4HANA, LIMS (LabVantage), warehouse automation (ASRS, WCS, AGV, EWM)
Validation & Compliance
- Validation support (CSV) — validation strategy, validation plan, risk analyses, IQ/OQ/PQ protocols writing, test execution, documentation (execution-level, per client Quality Unit approval)
- Technical & GMP documentation — SOPs, master batch records, qualification/validation reports
- Validation methodology & digital tools — Waterfall and Agile validation approaches; application of CSV/QMS e-VLM tools (Kneat, MasterControl, TrackWise)
Program & Project Management
- Digital architecture & Industry 4.0 roadmaps — vendor scouting, technology selection, URS authoring
- Program & project management — MES rollout coordination across multi-site, multi-vendor environments
- Vendor & system integrator coordination — scope, planning, risk management across parallel projects
- Cross-functional engineering — bridging Business, QA, Engineering, IT/OT stakeholders
Training & Support
- Training & knowledge transfer — end-user and technical team training on MES/automation platforms, DCS, and ISA-
95/88 data standards - Post-implementation support — site troubleshooting, continuous improvement
Technology & Standards
Platforms and frameworks we work with across MES, automation, historian, ERP and warehouse projects.
MES
PAS-X, PharmaSuite, POMS / POMSnet (incl. Weigh & Dispense), Tulip, Syncade, Honeywell TWM, Opcenter
DCS / SCADA / PLC
Emerson DeltaV, Siemens PCS7, Foxboro I/A Series, Schneider Electric, Siemens PLC, Allen-Bradley, Comi Condor
Data Gateways & Historians
Ignition, HighByte, COPADATA, AVEVA PI / OSI-PI, AspenTech Inmation
ERP / LIMS
SAP ECC, SAP S/4HANA, LabVantage LIMS
CMMS / Maintenance
IBM Maximo, electronic logbooks (MES–CMMS integration)
Warehouse & Logistics
ASRS, WCS, AGV, fleet management, SAP EWM
Standards & Frameworks
ISA-95, ISA-88, GxP, GAMP 5-aligned validation practices
Program Tools
JIRA Software, Primavera P6, Microsoft Project
BMS & EMS
Schneider Electric, Honeywell EBI
Standards & Frameworks
Standards and regulatory frameworks supporting manufacturing, quality, validation and logistics projects.
| Standard / Framework | Application / Description |
|---|---|
| ISA-95 | Manufacturing data standardization and harmonization of data models across sites |
| ISA-88 | Batch control and recipe standardization, coupled with ISA-95 |
| ISA-18.2 | Alarm management, including alarm rationalization and design |
| GxP | General regulatory quality framework |
| GAMP 5 | GAMP 5-aligned validation practices |
| ICH E6(R2) | Good Clinical Practice (GCP) Guidelines (certification) |
Basel, Switzerland — MES & automation engineering
Manufacturing systems built to hold up under GMP scrutiny.
Bruni Manufacturing Systems designs, integrates and validates the MES, automation and OT/IT systems that run regulated pharmaceutical production — from single recipe changes to multi-site digital rollouts.

