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ViPharma eBMR

ViPharma eBMR • Electronic Batch Manufacturing Record

Digitize. Execute. Verify. Approve. Trace.

Controlled Electronic Batch Manufacturing Records

ViPharma eBMR transforms traditional paper-based BMR execution into a structured, dynamic and traceable electronic workflow — from batch initiation and section-wise execution to review, approval and final BMR generation.

Dynamic BMR Controlled Execution Traceability Digital Reporting
ViPharma eBMR
Batch Execution
Dynamic Section & Field Configuration
Accountable User & Review Traceability
Controlled NLT / NMT Process Limits
Approved Review & Electronic Approval
ViPharma eBMR Pharmaceutical Manufacturing Electronic Batch Records

Electronic Batch Manufacturing Record for Controlled Batch Execution

ViPharma eBMR provides a controlled digital environment for recording manufacturing activities, process parameters, operator actions and review decisions against a specific product and batch. The platform is designed around structured batch execution, configurable fields, process limits, traceability and controlled reporting.

One Controlled Record From Batch Start to Final Approval

Product → BMR Version → Batch → Section → Parameter → Value → Review → Approval → Final BMR Report.

01. Digital Batch Manufacturing Record

Replace paper-based batch records with a structured electronic record that guides operators through the defined manufacturing workflow. Each execution entry remains associated with the relevant batch, section and configured parameter.

Product-wise BMR

Configure manufacturing records according to product and process requirements.

BMR Version Control

Maintain controlled versions of the batch record configuration.

Batch Tracking

Maintain batch number, batch size, stage and execution history.

Section-wise Execution

Execute only the relevant manufacturing section and parameters.

02. Dynamic BMR Configuration

Authorized users can configure BMR sections, subsections and parameters without creating a separate static screen for every manufacturing process. The structure can be aligned with the organization's manufacturing workflow.

TEXTOperator Entry
NUMBERProcess Value
DATESystem Date
TIMESystem Time
USEROperator ID
SELECTPredefined Value
  • Text, numeric, date and time fields
  • Automatic current date and time capture
  • Automatic operator/user identification
  • Dropdown and predefined values
  • Read-only system-generated fields
  • Mandatory field and configured review controls

03. Process Limit Controls – NLT / NMT

Process parameters can be configured with defined acceptance limits. Entered values can be automatically compared against the configured limits so that potentially invalid process entries are clearly identified.

NLT Not Less Than Minimum acceptable value
VS
NMT Not More Than Maximum acceptable value
Automatic Comparison Out-of-limit values can be visually highlighted.

04. Section-wise Batch Execution

Operators work against the selected batch and relevant manufacturing section. Multiple execution entries can be recorded while retaining the relationship between batch, section, field and value.

Batch Product & Batch
→
Section Manufacturing Stage
→
Parameters Configured Fields
→
Execute Capture Values
→
Review Verify & Approve

05. Electronic Data Capture & Traceability

Every captured parameter can be linked to a unique field and execution reference. This creates a clear relationship between the batch and the data recorded during manufacturing.

Traceability Level Captured Information Control
Batch Product, batch number, batch size, BMR version Controlled record
Section Manufacturing stage / section execution Section-wise history
Parameter Field ID, configured parameter, value Field-level traceability
User Operator / reviewer / approver User accountability
Time Execution, review and approval date/time Time-stamped record

06. Review & Approval Workflow

Review and approval can be incorporated into the batch execution workflow. This enables controlled verification of entries before the batch record reaches its final approved state.

01
Operator Entry

Execution data is captured against the batch.

02
Review

Configured entries can be reviewed with remarks.

03
Approval

Authorized reviewer/approver completes the workflow.

04
Final Record

Controlled BMR report can be generated and archived.

07. BMR Reporting & PDF Generation

ViPharma eBMR can generate a structured batch report containing product, batch, BMR version, execution data and relevant user/review information. The report can be designed for controlled A4 output and electronic archiving.

ViPharma Electronic Batch Manufacturing Record
eBMR
Product: __________________ Batch: __________________ BMR Version: __________
ParameterValueUserDate / Time
Process ParameterRecorded ValueOperatorDD/MM/YYYY HH:MM
Process ParameterRecorded ValueOperatorDD/MM/YYYY HH:MM
Prepared / Executed By Reviewed By Approved By
  • Batch-wise report
  • Section-wise reporting
  • BMR version in report
  • Product and batch information
  • Operator / reviewer / approver details
  • Signature sections
  • A4 print-ready format
  • PDF generation / archive capability

08. Security, Data Integrity & Compliance Controls

Role-based AccessControl who can configure, execute, review and approve.
Unique User IDMaintain individual accountability for electronic records.
Audit TrailTrack important transactions and controlled activities.
Date / Time StampRecord execution, review and approval timing.
Controlled ModificationRestrict unauthorized changes to configured records.
Record TraceabilityMaintain Batch → Section → Parameter → Value relationships.
Version ControlIdentify the BMR configuration applicable to a batch.
Electronic ApprovalSupport controlled review and approval workflows.

21 CFR Part 11 / GMP-Oriented Electronic Records

ViPharma eBMR is designed to support electronic record, user accountability, audit trail, access control, review and approval requirements. Final regulatory compliance depends on the configured system, intended use, validation/qualification and the customer's applicable procedures.

09. Complete eBMR Lifecycle

01BMR SetupProduct & Version
02BatchBatch Initiation
03ExecuteSection-wise Capture
04VerifyLimits & Review
05ApproveControlled Approval
06ReportFinal eBMR
07ArchiveTraceable Record

Built for Manufacturing Operations

From configurable manufacturing parameters to batch-wise execution, review and final reporting, eBMR creates one connected digital record for the manufacturing process.

Move From Paper BMR to Controlled Digital Batch Execution

Explore how ViPharma eBMR can be configured around your manufacturing process, products, batch records and review requirements.

Talk To Our eBMR Expert
Electronic Batch Manufacturing Record
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