Paper-based batch records
Thick printed BMR booklets are photocopied, transcribed and stored in rooms that inspectors want to see.
Electronic Batch Manufacturing Record (eBMR)
Digitize batch manufacturing with a paperless, compliant and intelligent eBMR platform that automates production execution, batch documentation, electronic approvals and batch release while ensuring complete traceability and regulatory compliance.
- 21 CFR Part 11
- EU GMP Annex 11
- Schedule M
- ALCOA+
OPS IQ eBMR
Batch Execution Control
18
Batches in progress
6
Awaiting QA review
98%
Right first time
Batch BN-24-0871 · Tablet 500 mg
Yield 98.4%Dispensing
Granulation
Compression
Packaging
Blender BL-04Line clearanceVerified
IPC — HardnessStage 3 checkIn limit
BN-24-0868QP releaseReleased
Paper slows the batch down long before release
Manual records, transcription and physical routing are where manufacturing loses time and where inspections find observations.
Batch release delays
Release waits on physical routing of the record between production, QA and the qualified person.
Manual data entry
Weights, yields and process parameters are copied by hand, then re-checked line by line.
Compliance risks
Illegible entries, missing initials and late signatures become data integrity observations.
Audit preparation burden
Every inspection means retrieving batch files, reconciling attachments and rebuilding the story.
Production inefficiency
Operators queue for documents and sign-offs instead of running the process on the shop floor.
Traditional paper BMR versus Nexgensis digital eBMR
The same GMP batch record — executed, verified and released by the system instead of by booklets and signature chases.
Traditional paper BMR
- Printed batch record booklets on every line
- Values written and transcribed after the step
- Physical BMR assembled across departments
- Signature books chased between shifts
- Batch status known only from the floor
- Wet-ink initials and dates
- Days of review, reconciliation and rework
- Trace built by hand from archived files
Nexgensis digital eBMR
- Fully paperless manufacturing execution
- Real-time data capture at the point of action
- One electronic batch record, always complete
- Automated, role-based approval workflow
- Live batch monitoring across every plant
- Part 11 compliant electronic signatures
- Exception-based, accelerated batch release
- Complete traceability from material to release
From recipe setup to electronic batch release
Every activity in the batch is digitally recorded as it happens, with a complete audit trail behind each entry, signature and correction.
01
Recipe Setup
Approved master formula and process steps configured under change control.
02
Batch Planning
Batch created against the master recipe with resources and schedule.
03
Raw Material Dispensing
Guided, verified weighing with barcode identification and balance capture.
04
Manufacturing Execution
Operators execute each step against electronic SOP guidance.
05
In-Process Checks
IPC results captured at defined stages with limit checks applied.
06
Packaging
Packaging operations, line clearance and reconciliation recorded digitally.
07
QA Review
Exception-based review of deviations, out-of-limit values and signatures.
08
Electronic Batch Release
Qualified person releases the batch with a bound electronic signature.
09
Archive
The complete record is locked, retained and retrievable with its audit trail.
Everything batch manufacturing needs, in one system
Guided, verified and fully traceable weighing
Dispensing is where most batch errors originate. The system identifies the material, guides the weight and records the result without transcription.
Scan material
Step 01
Verify status & lot
Step 02
Weigh to target
Step 03
Sign & post
Step 04
Barcode & QR Verification
Container and material identity scanned before any weighing begins.
Guided Weighing
Target, tolerance and sequence presented step by step to the operator.
Balance Integration
Weights read directly from the balance — no manual transcription.
Material Verification
Approved status, lot and expiry validated by the system in real time.
Dual Operator Verification
Second-person check enforced where the procedure requires it.
Electronic Signatures
Each dispensed item signed by operator and verifier.
Inventory Updates
Consumption posted against the batch and the warehouse balance.
Full Traceability
Every gram links back to a lot, container, balance and person.
The procedure, the data and the signature at the point of work
Operators are guided through each stage on screen, with prerequisites enforced and every value captured as the step is performed.
Production stage · Compression
Equipment verificationCP-02 · cleaned 14 AugComplete
Line clearanceOperator + verifierSigned
Process parametersLive from equipmentCaptured
IPC — hardness6.2 kp (5.0–8.0)In limit
Yield calculation98.4% reconciledAutomatic
Stage sign-offSupervisorPending
Electronic SOP Guidance
The current effective procedure is presented at the step it applies to.
Equipment Verification
Equipment identity, status and cleaning validity confirmed before use.
Digital Line Clearance
Line clearance completed and signed before the stage can start.
Step-by-Step Manufacturing
Sequence enforced — steps cannot be skipped or back-dated.
Live Data Capture
Process parameters captured as they happen, from instruments or operators.
Automatic Yield Calculation
Yield and reconciliation computed by the system, not by hand.
Real-Time Alerts
Out-of-limit values and missed checks alert supervision immediately.
Electronic Sign-Off
Each stage closed with an attributable electronic signature.
Exception-based review, accelerated release
The system checks the record before a reviewer opens it, so QA spends its time on exceptions rather than on page-by-page verification.
Automated Validation Checks
The system verifies completeness, limits, signatures and reconciliation.
Exception-Based Review
QA reviews only the exceptions instead of every page of the record.
Electronic QA Approval
Quality approval captured with identity, timestamp and reason.
Qualified Person Release
QP performs the final disposition decision on the electronic record.
Batch Certificate Generation
Certificate produced automatically from the released record.
ERP Update
Release status posted back to SAP or the connected ERP system.
Digital Archive
The record is locked and retained with its complete audit trail.
Deviations raised in the moment, closed with evidence
Out-of-limit values and missed steps create a deviation while the batch context is still live — not weeks later during review.
Detection
Logging
Impact Assessment
Investigation
Root Cause
CAPA
Effectiveness Check
Closure
Automatic Deviation Detection
Out-of-limit entries and missed steps raise a deviation as they occur.
Root Cause Analysis
Structured investigation tools linked to the batch context.
Investigation Workflow
Owners, due dates and approvals routed automatically.
CAPA Assignment
Corrective and preventive actions raised directly from the deviation.
Effectiveness Verification
Planned checks confirm the action worked before closure.
Trend Analysis
Recurring deviations trended by product, line, shift and cause.
Manufacturing performance, visible in real time
Live batch status for the floor, release performance for quality and cross-plant analytics for operations leadership.
0
Batches released this month
0
Average release cycle (hrs)
0%
Right first time
0%
Overall equipment effectiveness
Batch Status
Every batch in progress, on hold, under review or released.
Batch Release Performance
Review and release cycle time by product and plant.
Yield Trends
Yield and reconciliation trends across batches and campaigns.
OEE
Availability, performance and quality by line and equipment.
Production KPIs
Throughput, cycle time and schedule adherence in real time.
Right First Time
Batches completed without deviation or documentation error.
CAPA Performance
Open, overdue and effective actions arising from manufacturing.
Cross-Plant Analytics
Comparable performance across sites on one harmonised model.
One manufacturing core, connected end to end
Batch orders, materials, equipment data and release status flow between the shop floor, the laboratory and the enterprise without re-keying.
Enterprise systems
SAPOracle ERPMicrosoft Dynamics
Quality & laboratory
LIMSMESLaboratory Instruments
OPS IQ eBMR
Manufacturing core
Shop floor & platform
OPC-UAREST APIsActive DirectoryCloud Platforms
Bi-directional
Batch orders and material master flow in from ERP; consumption, yield and release status flow back — with the audit trail preserved on both sides.
Built for global regulated manufacturing
Batch records are governed by controls the system enforces, so inspection evidence is produced as a report rather than assembled as a project.
FDA 21 CFR Part 11
Electronic records and signatures with secure, computer-generated audit trails.
EU GMP Annex 11
Computerised system controls, access management and periodic review evidence.
WHO GMP
Batch documentation and record-keeping expectations for regulated manufacturing.
Schedule M
Indian GMP manufacturing and documentation requirements supported out of the box.
GAMP 5
Risk-based validation with documented lifecycle deliverables for each release.
ICH Q10
Pharmaceutical quality system principles applied to manufacturing execution.
ALCOA+
Attributable, legible, contemporaneous, original and accurate batch data.
Electronic Signatures
Meaning-bound signatures on execution, review and release steps.
Audit Trails
Every entry, correction and approval permanently recorded.
Data Integrity
System-enforced controls so integrity does not depend on individual discipline.
Production data, protected and attributable
Access, signatures, encryption and recovery are governed centrally — and every action on a batch leaves a permanent record.
Role-Based Access Control
Least-privilege access by role, site, line and batch stage.
Electronic Signatures
Re-authentication at the point of signature, bound to a stated meaning.
Immutable Audit Trail
Non-editable, time-stamped record of every action on every batch.
AES-256 Encryption
Batch data encrypted in transit and at rest across the platform.
Multi-Factor Authentication
MFA and SSO enforced for privileged manufacturing roles.
Disaster Recovery
Validated backup and tested restore procedures for production data.
Secure Cloud Deployment
Tenant-isolated, monitored deployment — cloud or on-premise.
Measurable manufacturing outcomes
0%
Faster batch release
0%
Reduction in documentation time
0%
Faster QA review
0
Manual calculation errors
Higher production efficiency
Operators run the process instead of managing paperwork and sign-offs.
Reduced compliance risk
Controls enforced by the system at the moment each entry is made.
Improved batch traceability
Material, equipment, person and result linked across the whole batch.
Real-time manufacturing visibility
Live batch, line and plant status without a floor walk or a phone call.
Built for regulated production
Pharmaceuticals
Biotechnology
Medical Devices
Nutraceuticals
Chemicals
Food & Beverage
Why manufacturers choose OPS IQ eBMR
Unified OPS IQ platform
eBMR shares one data model with eQMS, LIMS, ELN and DMS.
Built for regulated manufacturing
Designed around GMP batch execution, not adapted from generic workflow.
Native ERP integration
Batches, materials and release status synchronised with SAP and ERP.
Cloud or on-premise
Deploy in our validated cloud or inside your own data centre.
Pharma-grade compliance
Part 11, Annex 11, Schedule M and ALCOA+ enforced at record level.
Intelligent workflow automation
Sequencing, limit checks, alerts and escalation handled by the system.
Multi-site deployment
Harmonised recipes and reporting across every plant in the network.
Scalable architecture
From a single production line to an enterprise manufacturing network.
A validated path to paperless production
A structured, GAMP 5 aligned programme from process discovery through validation to hypercare on your first live campaigns.
01
Discovery & Design
Process mapping, recipe review and workflow design with your production and QA teams.
02
Configuration & Integration
Master formulas, workflows and ERP, LIMS, balance and OPC-UA connections configured.
03
Validation (IQ/OQ/PQ)
GAMP 5 risk-based validation with complete documented evidence.
04
User Training
Role-based training for operators, supervisors, QA reviewers and the qualified person.
05
Go-Live & Hypercare
Pilot line go-live, rollout and on-site hypercare through the first campaigns.
eBMR questions, answered
An electronic Batch Manufacturing Record replaces the paper BMR with a digital record that guides and captures every manufacturing step — dispensing, execution, in-process checks, packaging, QA review and release — as it happens.
Transform paper-based manufacturing into intelligent digital production
Digitize your manufacturing operations with Nexgensis eBMR to accelerate batch release, improve compliance, eliminate paper records and achieve complete production traceability.
- 45-minute working session on one of your own batch records
- Dispensing, execution, IPC and release walkthrough
- Validation and ERP integration evidence review