An MES that runs your plant, not a reference plant.
We design, implement, and integrate the MES execution layer on Microsoft Azure — configured to your master recipes, connected to the ERP, automation, historian, LIMS, and QMS you already run, and rolled out one line or site at a time. Validation and qualification stay with your team.
Electronic Batch Records — Configured to Your Recipes
We implement master batch records, work instructions, weighing and dispensing flows, equipment use, and electronic signatures — configured to your products, your SOPs, and your review gates — so operators execute against an approved record and reviewers work by exception.
Shop-Floor Execution & Equipment Management
Operator-guided execution on shop-floor terminals, equipment status and use logging, in-process check capture, and in-context deviation entry — wired into the execution engine so the batch record is built as the batch runs.
Material & Batch Genealogy at Batch Level
Material dispensing, lot and serial linkage, in-process and finished-goods relationships, and forward / backward genealogy — so recall trace, complaint follow-up, and deviation investigation are queries against an audited record, not multi-day spreadsheet exercises.
ERP, Automation, Historian, LIMS & QMS Integration
ISA-95-aligned engineering surface for orders, materials, BOMs, and confirmations to / from ERP; setpoints, equipment state, and process data from automation and the historian; result and specification exchange with LIMS; deviation and CAPA hand-off to QMS — over documented APIs your IT and automation teams control.
Microsoft Azure Landing Zone
Azure landing zone designed for manufacturing workloads — private networking, Microsoft Entra ID with MFA, Key Vault, monitoring via Application Insights and Log Analytics, environment promotion gates, and Terraform-defined infrastructure your security team can sign off.
BI, OEE & Shop-Floor Dashboards
Power BI dashboards on the MES data layer — batch status, OEE, deviation counts, in-process check results, electronic-record review backlog, and yield — surfaced for operators, supervisors, plant managers, and quality leadership on terminals, large-format boards, and the executive view.
Paperless Batch Records, In the Hands of Operators
Operator-guided execution on shop-floor terminals, in-line data capture, and electronic signatures at the step — so the record is built as the batch runs, not reconstructed after it.
Live Visibility From the Line to the Plant Manager
Power BI dashboards on the MES data layer surface batch status, line state, OEE, deviations, and in-process checks live — so supervisors, quality, and plant leadership are looking at the same numbers, in real time.
Engineered for electronic-record, audit-trail, and material-genealogy integrity
Electronic Records & Signature Configuration
Master batch records, work instructions, equipment management, and electronic signature workflows configured so each action is attributable to a person, a time, and an approved step. Validation and policy decisions stay with your Quality team.
Material & Batch Genealogy on the MES Data Layer
Forward and backward genealogy, lot and serial linkage, and material consumption are configured into the MES data model — so a recall trace or deviation investigation is a query, not a spreadsheet reconstruction.
Azure Landing Zone Engineered for Controlled Workloads
Microsoft Azure landing zone with private networking, Entra ID + MFA, Key Vault, monitoring, and Terraform-defined infrastructure — patterns your security team recognises and can review as part of your own qualification scope.
Six stages, one electronic batch record. The way your line actually runs.
Order release, material genealogy, EBR execution, in-process review, release, and yield — each stage configured to your master recipes, all running on a shared engineering foundation built for paperless throughput, live visibility, and trusted batch records.
Order Release
Manufacturing orders, recipes, and equipment assigned.
Material & Genealogy
Dispensing, lot/serial linkage, forward and backward trace.
EBR Execution
Operator-guided steps, in-line data, e-signatures.
In-Process Review
Checks, deviations, and review-by-exception queues.
Release & Closure
Disposition, genealogy closure, and record archive.
Yield & CI
OEE, deviations, and continuous improvement signals.
An MES layer on Microsoft Azure — designed, integrated & lifecycle-managed
- MES execution layer — configured to your master recipes, SOPs, review gates
- Microsoft Azure landing zone — identity, networking, monitoring, IaC
- ISA-95-aligned integration — ERP, automation, historian, LIMS, QMS
- Power BI on the MES data layer — batch status, OEE, deviations, review backlog
Compliance by design
Engineering artifacts for your validation work
We structure the implementation so your Quality and Validation teams have the configuration, change logs, integration runbooks, and test evidence they need to execute their own validation and qualification work. We do not perform validation on your behalf.
The audit trail as the system of record
Every batch step the MES executes — dispensing, equipment use, parameter capture, signature, deviation, review, disposition — is logged with actor, timestamp, action, and outcome, with Azure-side platform logs preserved alongside for end-to-end traceability.
Electronic signature configuration
Electronic batch record and signature workflows are configured so entries are attributable, contemporaneous, original, accurate, and reviewable. Policy decisions stay with your Quality team.
Material lineage & forward/backward genealogy
Material, lot, and serial linkage from receiving to finished goods is configured into the MES data model — so recall trace, deviation investigation, and complaint follow-up are queries against the audited record, not spreadsheet reconstructions.
Identity & role-scoped access on Azure
Microsoft Entra ID with enforced MFA, conditional access policies, role-scoped access for operator, supervisor, quality, automation, plant IT, and admin populations, and least-privilege defaults across the landing zone and APIs.
Microsoft Azure landing zone
Azure landing zone for controlled manufacturing workloads — private endpoints, Key Vault for secrets, Terraform-defined infrastructure, environment promotion gates, monitoring via Application Insights and Log Analytics, and backup / DR patterns your security and operations teams can sign.
Audit-ready on day one
Our implementation engineering — MES configuration, ISA-95-aligned integration, the Microsoft Azure landing zone, the BI layer, and lifecycle ops — is designed with audit-trail, electronic-record, material-genealogy, role-scoped-access, and platform-logging rigor so your Quality, Validation, and Regulatory teams have the artifacts they need for their own work. Validation execution, qualification, and any regulatory or inspection outcome remain solely the customer's responsibility. Sorento Software does not represent, attest, or warrant compliance with any regulatory framework on behalf of any customer.
Partner agreements in place
Cleaner, Faster Batch Release
Operator-guided execution, in-line data capture, electronic signatures, and review-by-exception compress the order-release → execution → review → disposition loop — and replace the printed batch records and post-batch reconciliation that slow release today.
Live Operational Signals for Plant Leadership
Power BI dashboards on the MES data layer surface batch status, OEE, deviation counts, in-process check results, and electronic-record review backlog — so plant managers, supervisors, and quality leadership act on the same numbers, at the same time.
Configured to Your Plant — Not a Reference Configuration
Your master recipes, your SOPs, your review gates, your reporting set. We configure the MES to the way your operators, supervisors, and quality reviewers actually work — without rewriting the plant around a generic reference configuration.
Batch Record Integrity Your Team Can Stand Behind
Every step is captured with actor, timestamp, equipment, materials, parameters, signatures, and outcome. The same execution layer that gives your team live visibility also gives quality and regulatory an evidence trail they can work from.
No Rip-and-Replace of Your Existing Stack
The MES is designed to coexist with the ERP, control system, historian, LIMS, and QMS you already run. We build the ISA-95-aligned integration surface; your IT and automation teams own the connectors, so existing qualification work is preserved.
Our Implementation Process
Discovery, Process Mapping & Implementation Framing
We walk your order-release, dispensing, execution, in-process check, review, and disposition workflows; inventory your existing ERP, automation, historian, LIMS, and QMS; identify electronic-record, audit-trail, and genealogy gaps; and frame the MES scope and the ISA-95 integration surface — before scoping the build. Validation strategy and qualification decisions stay with your Quality and Validation function.
Cloud Landing Zone & Implementation Plan
Stand up the Microsoft Azure landing zone — identity (Microsoft Entra ID), private networking, Key Vault, monitoring, and Terraform-defined infrastructure. Design the MES configuration scope (master batch records, weighing, equipment management, electronic signatures), the ISA-95-aligned integration surface, and the BI layer alongside your IT, automation, security, and quality stakeholders.
MES Configuration, Integration Build & Iteration
Iterative configuration of the MES to your master recipes, work instructions, equipment, and review gates; build of the ERP / automation / historian / LIMS / QMS integration surface; and the Power BI layer on top — with engineering artifacts (test coverage, change logs, configuration history) captured as part of the build. Line-by-line demos with operators, supervisors, and quality keep the platform anchored to real production work.
UAT & Handoff to Your Quality / Validation Function
Run UAT with operations, automation, and quality stakeholders. Assemble the engineering documentation set your Quality team uses as inputs into their own validation and qualification work. We do not perform validation or qualification on your behalf.
Phased Go-Live, Hypercare & Lifecycle Operations
Line-by-line or site-by-site go-live so a single production area can run on the MES while the rest of the plant continues uninterrupted. An initial hypercare period covers monitoring, defect triage, change-control engineering, and tuning so the platform stays in a known state as your master recipes, products, and processes evolve.
Frequently Asked Questions
Do you build the MES yourselves, or implement an off-the-shelf product?
Both paths are on the table, and the decision belongs in discovery rather than on a public page. Some sites are best served by configuring and integrating an established execution product; others need a purpose-built execution layer around the workflows their line actually runs. What we bring either way is the same: discovery, configuration or build, the ISA-95-aligned integration surface into your ERP, automation, historian, LIMS, and QMS, the Microsoft Azure landing zone, the BI layer, hypercare, and lifecycle ops. We are not a reseller and hold no vendor licensing incentive, so the recommendation is based on engineering fit.
Why Microsoft Azure — what is the stack rationale?
Azure gives us a landing zone pattern that regulated manufacturers can already reason about: identity through Microsoft Entra ID, private networking, secrets management in Key Vault, monitoring through Application Insights and Log Analytics, backup and DR, and infrastructure defined in Terraform. In most plants we work with, IT and security already operate an Azure estate, so the MES lands inside a security and operations model your team recognises instead of introducing a parallel one.
How does the MES fit alongside our existing ERP, automation, historian, LIMS, and QMS?
The MES is designed to coexist with the ERP, control system, historian, LIMS, and QMS you already run — using documented APIs and standard data exchange formats aligned with ISA-95 boundaries. We design and build the integration surface; your IT and automation teams own the connectors into the existing stack, so qualification work you have already done is preserved. We name those systems by category, not by product, because we do not claim partnerships or pre-built connectors with any third-party ERP, automation, or historian vendor.
Can we roll the MES out one line or site at a time instead of a single cutover?
Yes — this is the default approach, not an option. Single "big bang" MES cutovers are one of the most common failure modes in regulated manufacturing programs, and we design against them. Each line or site is implemented to go live independently, with clear data and integration boundaries. This lets you prove operational fit on one line, train operators and supervisors incrementally, and expand the rollout without pausing commercial supply.
How does the implementation handle electronic batch records and audit trails?
The execution layer captures every step with actor, timestamp, equipment, materials, parameters, signatures, and outcome, and we configure the master batch records, work instructions, weighing and dispensing, equipment management, and signature flows so entries are attributable, contemporaneous, original, accurate, and reviewable. Validation execution, policy decisions, and any inspection outcome remain with your Quality and Validation function; we do not certify or attest to regulatory compliance on your behalf.
What does a typical engagement look like, and how do you scope it?
Engagement scope, timeline, and investment vary by plant and are defined during discovery — we do not quote fixed durations or fixed outcomes on a public page. Discovery is where we map your production workflows, inventory the systems you already run, agree the MES module scope and the ISA-95 integration surface, and frame the Azure landing zone before any production-bound work begins. The build is typically phased so the highest-priority line goes live first and your team can review the platform before later phases land.
Ready to put an MES on your shop floor?
Book a free 30-minute discovery call. We will walk through your production workflows, the systems you already run, the MES module scope, and the Microsoft Azure landing zone — and outline a realistic, phased implementation for your plant. Validation and qualification stay with your team.