Replace paper batch records, one line at a time.
We design, implement, and integrate the Electronic Batch Record layer on Microsoft Azure — configured to your master recipes, connected to the ERP, automation, historian, LIMS, and QMS you already run, and rolled out line by line. Validation, qualification, and any inspection outcome stay with your team.
Electronic Master Batch Records & E-Signatures
We configure 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.
Operator-Guided Execution on Shop-Floor Terminals
Operator-guided execution, in-line data capture, equipment status logging, in-process check entry, and in-context deviation capture — wired into the execution engine so the batch record is built as the batch runs.
Review by Exception, Not Page by Page
Reviewers see deviations, missed limits, and exception queues — not every conforming line of every batch. The same review workflow can route to operations supervision, quality, and disposition with full e-signature traceability.
Material & Batch Genealogy on the EBR Data Layer
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 the 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 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 controlled 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.
Paperless Execution, in the Hands of Operators
Operator-guided steps, in-line data capture, and electronic signatures at the step — so the batch record is built as the batch runs, not reconstructed from a paper pack after disposition.
Review by Exception, From Line to Disposition
Reviewers see only the deviations, missed limits, and exceptions queued for them — not every conforming page of every batch. Disposition is signed against the audited electronic record.
Engineered for electronic-record, audit-trail, and data-integrity rigor
eMBR & E-Signature Configuration
Master batch records, work instructions, equipment use, 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.
Audit Trail on the EBR Layer
Every batch step is logged with actor, timestamp, action, equipment, materials, parameters, signatures, and outcome — attributable, contemporaneous, original, accurate, complete, consistent, enduring, and available by design.
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.
Built as the batch runs, not reconstructed after.
Every paper batch-record friction point — late error capture, post-batch reconciliation, spreadsheet genealogy, physical archive — replaced by an in-line electronic equivalent. QA reviews by exception instead of by page.
Printed master batch record
Approved PDF → printed pack at line release. Revision drift between sites is a constant risk.
Hand-written execution
Operators write timestamps, weights, equipment IDs, and signatures by hand on the pack as the batch runs.
Errors caught late
Missed entries, illegible writing, late corrections — surfaced hours or days after the step.
Post-batch reconciliation
QA reviews every page of every batch — full-record review, not by exception.
Genealogy by spreadsheet
Recall trace and deviation investigation pieced together from scanned pages and shared drives.
Paper archive
Physical storage, retrieval lag, and data-integrity exposure across the retention period.
Configured electronic MBR
Master batch record, work instructions, and review gates configured to your SOPs — versioned in the system, not in a binder.
Operator-guided execution
Steps, weights, equipment, parameters, and e-signatures captured in-line on shop-floor terminals as the batch runs.
In-line edit checks
Limits, ranges, equipment status, and material checks enforced at the step — not days later in QA.
Review by exception
QA reviewers see only the deviations and exceptions queued for them — not every conforming page of every batch.
Genealogy as a query
Forward / backward lot and serial linkage modeled into the data layer — recall trace and deviation investigation become queries.
Audited electronic archive
Records, audit trails, and signatures retained in the electronic record with role-scoped access and exportable evidence.
EBR delivery on a validated execution layer and a regulated-workload cloud
- Electronic records and signatures engineered to be attributable, contemporaneous, original, accurate, and reviewable
- Microsoft Entra ID, role-scoped access, and audit-trail logging on the EBR execution layer
- ISA-95-aligned integration to ERP, automation, historian, LIMS, and QMS — coexists with the stack you already run
- Deployed on a Microsoft Cloud landing zone your IT and security teams already operate
Compliance by design
Engineering artifacts for your validation work
We structure the EBR 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 EBR 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 EBR 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 — EBR configuration, ISA-95-aligned integration, the Microsoft Azure landing zone, 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.
Batch Record Integrity Your Team Can Stand Behind
Every step is captured with actor, timestamp, equipment, materials, parameters, signatures, and outcome on the EBR audit trail — so quality and regulatory work from the same record your operators do, with data-integrity rigor engineered in.
Configured to Your Plant — Not a Reference Configuration
Your master recipes, your SOPs, your review gates, your reporting set. We configure the EBR layer to the way your operators, supervisors, and quality reviewers actually work — without rewriting the plant around a generic reference build.
No Rip-and-Replace of Your Existing Stack
The EBR layer 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.
EBR Now, MES Later — Without Re-Platforming
EBR is the highest-impact piece of an MES program. We scope and deliver the EBR layer first so the paper goes away on the line that needs it most, and the surrounding modules (equipment management, scheduling, OEE, advanced genealogy) can be added in later phases on the same execution platform.
Our Implementation Process
Discovery, Paper-Record Walkthrough & Implementation Framing
We walk your current paper batch record, dispensing, in-process check, review, and disposition workflows; inventory the ERP, automation, historian, LIMS, and QMS in scope; identify electronic-record, audit-trail, and genealogy gaps; and frame the EBR 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 & EBR Implementation Plan
Stand up the Microsoft Azure landing zone — identity (Microsoft Entra ID), private networking, Key Vault, monitoring, and Terraform-defined infrastructure. Design the EBR configuration scope (master batch records, weighing, equipment, electronic signatures), the ISA-95-aligned integration surface, and the review workflow alongside your IT, automation, security, and quality stakeholders.
EBR Configuration, Integration Build & Iteration
Iterative configuration of master batch records, work instructions, equipment, and review gates; build of the ERP / automation / historian / LIMS / QMS integration surface; and the review-by-exception workflow — 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 EBR 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 paperless while the rest of the plant continues uninterrupted. An initial hypercare period covers monitoring, defect triage, change-control engineering, and tuning so the EBR layer stays in a known state as your master recipes, products, and processes evolve.
Frequently Asked Questions
Do we need a full MES, or can EBR alone solve our paper batch record problem?
For many sites, EBR alone is the right first move. EBR is the highest-impact piece of an MES program — it removes the paper from operator execution, captures electronic signatures, and gives reviewers a review-by-exception workflow. We can implement EBR as a standalone engagement, then add the surrounding MES modules (equipment management, weighing & dispensing as a full module, scheduling, OEE) in later phases on the same execution platform — without re-platforming.
Do you build the EBR 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 EBR 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, 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 EBR lands inside a security and operations model your team recognises instead of introducing a parallel one.
How is the electronic record kept trustworthy — signatures, audit trail, and data integrity?
Every batch step is captured with actor, timestamp, equipment, materials, parameters, signatures, and outcome on the audit trail, and we configure master batch records, work instructions, equipment use, signature flows, and review queues so entries are attributable, contemporaneous, original, accurate, complete, 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.
How does the EBR fit alongside our existing ERP, automation, historian, LIMS, and QMS?
The EBR layer 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 go paperless one line or one site at a time?
Yes — this is the default approach, not an option. Single "big bang" EBR 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.
What does a typical EBR 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 walk your current paper batch record, map the surrounding system estate, agree the EBR module scope, and frame the Microsoft 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 EBR before later phases land.
Ready to retire your paper batch records?
Book a free 30-minute discovery call. We will walk through your current paper batch record, the systems you already run, the EBR scope that fits your line, and the Microsoft Azure landing zone — and outline a realistic, phased rollout for your plant. Validation and qualification stay with your team.