Electronic batch record management
- Digital batch templates
- Version-controlled records
- Master document linking
- Controlled changes
eBMR
The Current Problem
Why Paper Batch Records Hold Back Digital Manufacturing
Disconnected processes create bottlenecks in review, traceability, data integrity, and compliance.
Paper batch record
MSB Docs eBMR
Illustrative flow. Timing varies by product and site.
Why It Hurts?
Where does GMP Documentation slow you down?
Every person who touches a batch record faces a different challenge, from data entry and review to approval and release.
The batch is complete. You’re still reviewing page 14 of 62.
Paper records require sequential review, and every missing or incorrect entry can send the record back for correction.
On paper today
- Sequential record reviews
- Manual verification of entries
- Delays in batch release
With MSB Docs eBMR
- Structured QA review queues
- Exceptions and discrepancies are surfaced
- Approval routes automatically to the next signer
Core Product Modules
eBMR Modules for Manufacturing and Quality Teams
Purpose-built modules streamline GMP Documentation, approvals, e-signatures, audit trails, and batch workflows across Digital Manufacturing operations.
Manufacturing activity documentation
- Step-based activity capture
- Operator entries
- Evidence attachments
- Real-time status
Quality review workflow
- QA review queues
- Exception handling
- Comments & corrections
- Approval routing
Electronic signatures
- Operator signing
- Supervisor approval
- QA release
- Complete signature history
Audit trail & data integrity
- User activity history
- Timestamp tracking
- Change records
- Complete traceability
Document & evidence repository
- SOP references
- Certificates
- Reports
- Supporting documents
The Complete eBMR Lifecycle
From master record to closed, archived batch
01
Master Batch Record Setup
Controlled recipe and template configuration.
WhoMBR author, QA approver
RecordVersion-controlled master template
ControlControlled changes with approval
02
Batch Creation
Batch-specific record generated for execution.
WhoProduction planning
RecordIssued batch record linked to its master
ControlCopy control, one issued record per batch
03
Execution Documentation
Manufacturing activity captured digitally.
WhoOperators, supervisors
RecordStep entries, evidence attachments, real-time status
ControlSigned at each step, time-stamped
04
Quality Review
Review by exception, deviations surfaced.
WhoQA reviewers
RecordReview queue, comments and corrections
ControlDeviations linked to the step they affect
05
Approval & E-Signature
Multi-level compliant sign-off.
WhoSupervisor, QA, release approver
RecordSignature history with meaning and time
ControlPart 11 compliant electronic signatures
06
Closure & Archival
Secure retention with full audit history.
WhoQA, records management
RecordClosed batch record with all evidence
ControlSearchable, inspection-ready archive
Integration ecosystem
A compliance layer that connects to what you already run
SAPTSPG-SuiteAWSMicrosoftThalesDrawinboxSharepointSalesforceBox
DocumentumOracleLegalConnectKytesProvakilSimpli ContractProteanCapriconE-Lock
Why MSB Docs eBMR
Beyond Conventional eBMR
Conventional eBMR solutions digitize paper records. MSB Docs eBMR goes further by managing the complete batch record lifecycle, from signing and vault storage to copy control, versioning, and audit traceability.
Comparison Area
Traditional eBMRDigitizes paper
MSB Docs eBMRRecommended
Primary Focus
Digitizing paper batch records into electronic formats
Creating controlled digital workflows for batch records, approvals, and compliance
Record Management
Static electronic forms replacing paper documents
Dynamic, configurable electronic records with workflow-based lifecycle management
Workflow Automation
Limited or manual routing of records for review
Configurable approval workflows with automated routing and status tracking
Electronic Signatures
Basic signing capability
Context-aware electronic signatures linked with user identity, action, and audit history
Review Process
Manual review of complete batch records
Structured digital review workflows with better visibility into pending actions and exceptions
Audit Trail
Basic activity tracking
Complete traceability of record creation, modification, approval, and lifecycle events
Document Control
Batch record focused
Integrated document lifecycle management with controlled versions and supporting evidence
Compliance Readiness
Stores electronic records
Maintains inspection-ready records with controlled workflows and audit evidence
Integration Capability
Limited integration options
Connects with enterprise applications and existing manufacturing ecosystems
User Experience
Digital replacement of paper processes
Collaborative compliance platform for operators, QA, reviewers, and approvers
Business Impact
What Electronic Batch Manufacturing Records change
page-by-page checking
Faster QA review
Review by exception replaces sequential, page-by-page checking.
redundant manual entry
Reduced documentation effort
Guided digital capture removes redundant manual entry.
searching archive boxes
Improved audit readiness
Complete, searchable evidence and approval history, always available.
integrity checks after the fact
Better data integrity
ALCOA+ controls built into every record, not bolted on after.
printed, carried, filed
Reduced paper dependency
Execution, review and approval move fully into digital workflows.
"where is that batch?"
Improved operational visibility
Real-time status across batches, sites and approval stages.
Industries
Built for regulated manufacturing, at any scale
Pharma
Pharmaceutical Manufacturing
Formulations, APIs, injectables.
Biotech
Biotech
Biologics, cell & gene therapy.
CDMO / CMO
Contract Manufacturing
Multi-client manufacturing documentation.
MedTech
Medical Devices
Device history records.
Frequently Asked Questions
What pharma teams ask before adopting eBMR
Can't find your question? A compliance specialist can walk you through it.
What is an eBMR?
An Electronic Batch Manufacturing Records replaces paper batch documentation with a digital, controlled record of every manufacturing activity, review, and approval.
What's the difference between eBMR and MES?
An MES focuses on executing and sequencing shop-floor operations. MSB Docs eBMR focuses on the controlled record, compliance workflow, and evidence that surrounds that execution.
How does eBMR support 21 CFR Part 11?
Through compliant electronic signatures, complete audit trails, controlled electronic records, and authenticated user access at every step.
How are electronic signatures managed?
Each signature is tied to a verified user identity, timestamp, and specific action — operator, supervisor, QA, and final release approvals are all captured with full history.
How does eBMR improve batch review?
Structured digital records and review-by-exception let QA focus on deviations and exceptions instead of re-checking every entry manually.
Can it integrate with our existing MES, LIMS, or QMS?
Yes. MSB Docs is built to connect with manufacturing, quality, and enterprise systems already in place rather than replace them.
How does MSB Docs support regulatory audits?
Every record, change, and approval is timestamped and searchable, so evidence can be retrieved quickly during an inspection.
Can workflows be configured per product or site?
Yes. Templates, approval routing, and review workflows are configurable by product, process, and site.
Does MSB Docs replace our current MES?
No. It adds a compliance and documentation layer on top of your existing manufacturing systems.
What industries use MSB Docs eBMR?
Pharmaceutical manufacturing, biotech, CDMO/CMO organizations, and medical device manufacturers.
Next step
Build the compliance layer your batch records have been missing
Move from paper to Electronic Batch Manufacturing Records with one controlled, audit-ready digital record.
Batch release · BR-2026-0417Step 5 of 6
✓ RELEASED