Electronic Batch Manufacturing Records (eBMR)

Need for this
eBMR

The pharmaceutical industry operates under rigorous quality and compliance standards, where precision, documentation, and traceability are vital. Traditional paper-based Batch Manufacturing Records (BMR) systems are increasingly inadequate for modern manufacturing challenges. The pressing need for eBMR (Electronic Batch Manufacturing Records) arises due to several key factors: 

Manual Errors: Handwritten entries are prone to mistakes, leading to data inaccuracies.
Delayed Reviews: Physical records necessitate time-consuming reviews, delaying batch releases.
Audit and Inspection Challenges: Ensuring adherence to regulatory audits and inspections with quick access to historical records and deviations is critical.
Data Integrity Issues: Maintaining ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more) is difficult without digital systems.
Benefits of Implementing eLogbooks

Adopting electronic logbooks offers numerous advantages: 

Minimizes Errors

Digital entries with validations and auto-capture reduce manual mistakes.

Faster Batch Release

Real-time QA review and e-signatures speed up approvals.

Audit-Ready

Instant access to records with complete audit trails.

Data Integrity

Ensures ALCOA+ compliance with secure, time-stamped entries.
Process Diagram
1

Recipe Management:

Define manufacturing recipes and workflows within ProcessXE.
2

Work Order Initiation

Generate electronic work orders linked to specific batches.
3

Real-time Data Capture

Operators input data directly into the system via user-friendly interfaces or integrate with equipment for automatic data collection.
4

In-process Checks

System prompts for quality checks at predefined stages, ensuring compliance.
5

Deviation Management

Automatically flags deviations and initiates corrective actions.
6

Review & Approval

Quality assurance teams review records electronically, with audit trails ensuring transparency.
7

Batch Release

Upon approval, batches are released, and records are archived for future audits.
eBMR with Process XE®
Operatory-friendly Interface: Simplifies data entry for operators, reducing training time.
Real-time Monitoring: Provides real-time tracking of batch progress and KPIs.
Plant Insights: Process insights to eliminate production delays, identify pending tasks, prevent deviations and optimize manufacturing in real time.
Regulatory Compliance: Ensures adherence to global standards such as USFDA, EDQM, WHO etc with built-in compliance checks.
Integration Capabilities: Connects seamlessly with ERP, eQMS, LIMS, and other enterprise systems.
Audit Readiness: Maintains comprehensive audit trails, facilitating inspections and audits.
Results of Implementation

70% reduction in overall batch review and approval time

50% improvement in batch release

25% reduction in documentation handling time

80% reduction in manual entry errors


30% reduction in paper costs